COVID-19 Clinical Trial
— KICC-COVID19Official title:
Keto-diet for Intubated Critical Care COVID-19 (KICC-COVID19)
Verified date | August 2020 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Coronavirus disease (COVID-2019) is a devastating viral illness that originated in Wuhan
China in late 2019 and there are nearly 2 million confirmed cases. The mortality rate is
approximately 5% of reported cases and over half of patients that require mechanical
ventilation for respiratory failure. As the disease continues to spread, strategies for
reducing duration of ventilator support in patients with COVID-19 could significantly reduce
morbidity and mortality of these individuals and future patients requiring this severely
limited life-saving resource. Methods to improve gas exchange and to reduce the inflammatory
response in COVID-19 are desperately needed to save lives.
The ketogenic diet is a high fat, low carbohydrate, adequate-protein diet that promotes
metabolic ketosis (ketone body production) through hepatic metabolism of fatty acids. High
fat, low carbohydrate diets have been shown to reduce duration of ventilator support and
partial pressure carbon dioxide in patients with acute respiratory failure. In addition,
metabolic ketosis reduces systemic inflammation. This mechanism could be leveraged to halt
the cytokine storm characteristic of COVID-19 infection.
The hypothesis of this study is that the administration of a ketogenic diet will improve gas
exchange, reduce inflammation, and duration of mechanical ventilation. The plan is to enroll
15 intubated patients with COVID 19 infection and administer a 4:1 ketogenic formula during
their intubation.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 31, 2021 |
Est. primary completion date | September 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Patients age 18 and older. - COVID-19 positive and respiratory failure requiring intubation - Legally authorized representative Exclusion Criteria: - Unstable metabolic condition - Liver failure - Acute Pancreatitis - Inability to tolerate enteral feeds, ileus, gastrointestinal bleeding - Known Pregnancy - Received propofol infusion within 24 hours - Known fatty acid oxidation disorder or pyruvate carboxylase deficiency |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University |
al-Saady NM, Blackmore CM, Bennett ED. High fat, low carbohydrate, enteral feeding lowers PaCO2 and reduces the period of ventilation in artificially ventilated patients. Intensive Care Med. 1989;15(5):290-5. — View Citation
Bae HR, Kim DH, Park MH, Lee B, Kim MJ, Lee EK, Chung KW, Kim SM, Im DS, Chung HY. ß-Hydroxybutyrate suppresses inflammasome formation by ameliorating endoplasmic reticulum stress via AMPK activation. Oncotarget. 2016 Oct 11;7(41):66444-66454. doi: 10.18632/oncotarget.12119. — View Citation
Baumeister FA, Oberhoffer R, Liebhaber GM, Kunkel J, Eberhardt J, Holthausen H, Peters J. Fatal propofol infusion syndrome in association with ketogenic diet. Neuropediatrics. 2004 Aug;35(4):250-2. — View Citation
Brožová K, Brož J. The risk of hypoglycemia and the ketogenic diet for super-refractory status epilepticus patients. Brain Dev. 2019 Sep;41(8):740. doi: 10.1016/j.braindev.2019.02.008. Epub 2019 Feb 22. — View Citation
Buyken AE, Goletzke J, Joslowski G, Felbick A, Cheng G, Herder C, Brand-Miller JC. Association between carbohydrate quality and inflammatory markers: systematic review of observational and interventional studies. Am J Clin Nutr. 2014 Apr;99(4):813-33. doi: 10.3945/ajcn.113.074252. Epub 2014 Feb 19. Review. — View Citation
Cervenka MC, Hartman AL, Venkatesan A, Geocadin RG, Kossoff EH. The ketogenic diet for medically and surgically refractory status epilepticus in the neurocritical care unit. Neurocrit Care. 2011 Dec;15(3):519-24. doi: 10.1007/s12028-011-9546-3. — View Citation
Cervenka MC, Henry BJ, Felton EA, Patton K, Kossoff EH. Establishing an Adult Epilepsy Diet Center: Experience, efficacy and challenges. Epilepsy Behav. 2016 May;58:61-8. doi: 10.1016/j.yebeh.2016.02.038. Epub 2016 Apr 6. — View Citation
Cervenka MC, Hocker S, Koenig M, Bar B, Henry-Barron B, Kossoff EH, Hartman AL, Probasco JC, Benavides DR, Venkatesan A, Hagen EC, Dittrich D, Stern T, Radzik B, Depew M, Caserta FM, Nyquist P, Kaplan PW, Geocadin RG. Phase I/II multicenter ketogenic diet study for adult superrefractory status epilepticus. Neurology. 2017 Mar 7;88(10):938-943. doi: 10.1212/WNL.0000000000003690. Epub 2017 Feb 8. — View Citation
Chen C, Zhang XR, Ju ZY, He WF. [Advances in the research of mechanism and related immunotherapy on the cytokine storm induced by coronavirus disease 2019]. Zhonghua Shao Shang Za Zhi. 2020 Jun 20;36(6):471-475. doi: 10.3760/cma.j.cn501120-20200224-00088. Review. Chinese. — View Citation
Correction to Lancet Respir Med 2020; published online Feb 21. https://doi.org/10.1016/S2213-2600(20)30079-5. Lancet Respir Med. 2020 Apr;8(4):e26. doi: 10.1016/S2213-2600(20)30103-X. Epub 2020 Feb 28. — View Citation
Deora V, Albornoz EA, Zhu K, Woodruff TM, Gordon R. The Ketone Body ß-Hydroxybutyrate Does Not Inhibit Synuclein Mediated Inflammasome Activation in Microglia. J Neuroimmune Pharmacol. 2017 Dec;12(4):568-574. doi: 10.1007/s11481-017-9754-5. Epub 2017 Aug 23. — View Citation
Dupuis N, Curatolo N, Benoist JF, Auvin S. Ketogenic diet exhibits anti-inflammatory properties. Epilepsia. 2015 Jul;56(7):e95-8. doi: 10.1111/epi.13038. Epub 2015 May 23. — View Citation
Fraser DA, Thoen J, Bondhus S, Haugen M, Reseland JE, Djøseland O, Førre O, Kjeldsen-Kragh J. Reduction in serum leptin and IGF-1 but preserved T-lymphocyte numbers and activation after a ketogenic diet in rheumatoid arthritis patients. Clin Exp Rheumatol. 2000 Mar-Apr;18(2):209-14. — View Citation
Fraser DA, Thoen J, Djøseland O, Førre O, Kjeldsen-Kragh J. Serum levels of interleukin-6 and dehydroepiandrosterone sulphate in response to either fasting or a ketogenic diet in rheumatoid arthritis patients. Clin Exp Rheumatol. 2000 May-Jun;18(3):357-62. — View Citation
Fried PI, McClean PA, Phillipson EA, Zamel N, Murray FT, Marliss EB. Effect of ketosis on respiratory sensitivity to carbon dioxide in obesity. N Engl J Med. 1976 May 13;294(20):1081-6. — View Citation
Goldberg EL, Asher JL, Molony RD, Shaw AC, Zeiss CJ, Wang C, Morozova-Roche LA, Herzog RI, Iwasaki A, Dixit VD. ß-Hydroxybutyrate Deactivates Neutrophil NLRP3 Inflammasome to Relieve Gout Flares. Cell Rep. 2017 Feb 28;18(9):2077-2087. doi: 10.1016/j.celrep.2017.02.004. — View Citation
Ji Y, Ma Z, Peppelenbosch MP, Pan Q. Potential association between COVID-19 mortality and health-care resource availability. Lancet Glob Health. 2020 Apr;8(4):e480. doi: 10.1016/S2214-109X(20)30068-1. Epub 2020 Feb 25. — View Citation
Kossoff EH, Zupec-Kania BA, Auvin S, Ballaban-Gil KR, Christina Bergqvist AG, Blackford R, Buchhalter JR, Caraballo RH, Cross JH, Dahlin MG, Donner EJ, Guzel O, Jehle RS, Klepper J, Kang HC, Lambrechts DA, Liu YMC, Nathan JK, Nordli DR Jr, Pfeifer HH, Rho JM, Scheffer IE, Sharma S, Stafstrom CE, Thiele EA, Turner Z, Vaccarezza MM, van der Louw EJTM, Veggiotti P, Wheless JW, Wirrell EC; Charlie Foundation; Matthew's Friends; Practice Committee of the Child Neurology Society. Optimal clinical management of children receiving dietary therapies for epilepsy: Updated recommendations of the International Ketogenic Diet Study Group. Epilepsia Open. 2018 May 21;3(2):175-192. doi: 10.1002/epi4.12225. eCollection 2018 Jun. — View Citation
McDonald TJW, Cervenka MC. Ketogenic Diets for Adults With Highly Refractory Epilepsy. Epilepsy Curr. 2017 Nov-Dec;17(6):346-350. doi: 10.5698/1535-7597.17.6.346. — View Citation
McDonald TJW, Henry-Barron BJ, Felton EA, Gutierrez EG, Barnett J, Fisher R, Lwin M, Jan A, Vizthum D, Kossoff EH, Cervenka MC. Improving compliance in adults with epilepsy on a modified Atkins diet: A randomized trial. Seizure. 2018 Aug;60:132-138. doi: 10.1016/j.seizure.2018.06.019. Epub 2018 Jun 22. — View Citation
Park EG, Lee J, Lee J. The ketogenic diet for super-refractory status epilepticus patients in intensive care units. Brain Dev. 2019 May;41(5):420-427. doi: 10.1016/j.braindev.2018.12.007. Epub 2019 Jan 9. — View Citation
Peng P, Peng J, Yin F, Deng X, Chen C, He F, Wang X, Guang S, Mao L. Ketogenic Diet as a Treatment for Super-Refractory Status Epilepticus in Febrile Infection-Related Epilepsy Syndrome. Front Neurol. 2019 Apr 26;10:423. doi: 10.3389/fneur.2019.00423. eCollection 2019. — View Citation
Rubini A, Bosco G, Lodi A, Cenci L, Parmagnani A, Grimaldi K, Zhongjin Y, Paoli A. Effects of Twenty Days of the Ketogenic Diet on Metabolic and Respiratory Parameters in Healthy Subjects. Lung. 2015 Dec;193(6):939-45. doi: 10.1007/s00408-015-9806-7. Epub 2015 Sep 26. Erratum in: Lung. 2016 Nov 1;:. — View Citation
Ruskin DN, Ross JL, Kawamura M Jr, Ruiz TL, Geiger JD, Masino SA. A ketogenic diet delays weight loss and does not impair working memory or motor function in the R6/2 1J mouse model of Huntington's disease. Physiol Behav. 2011 Jul 6;103(5):501-7. doi: 10.1016/j.physbeh.2011.04.001. Epub 2011 Apr 9. — View Citation
Schreck KC, Lwin M, Strowd RE, Henry-Barron BJ, Blakeley JO, Cervenka MC. Effect of ketogenic diets on leukocyte counts in patients with epilepsy. Nutr Neurosci. 2019 Jul;22(7):522-527. doi: 10.1080/1028415X.2017.1416740. Epub 2017 Dec 18. — View Citation
Tagliabue A, Bertoli S, Trentani C, Borrelli P, Veggiotti P. Effects of the ketogenic diet on nutritional status, resting energy expenditure, and substrate oxidation in patients with medically refractory epilepsy: a 6-month prospective observational study. Clin Nutr. 2012 Apr;31(2):246-9. doi: 10.1016/j.clnu.2011.09.012. Epub 2011 Oct 20. — View Citation
Thakur KT, Probasco JC, Hocker SE, Roehl K, Henry B, Kossoff EH, Kaplan PW, Geocadin RG, Hartman AL, Venkatesan A, Cervenka MC. Ketogenic diet for adults in super-refractory status epilepticus. Neurology. 2014 Feb 25;82(8):665-70. doi: 10.1212/WNL.0000000000000151. Epub 2014 Jan 22. — View Citation
van den Berg B, Bogaard JM, Hop WC. High fat, low carbohydrate, enteral feeding in patients weaning from the ventilator. Intensive Care Med. 1994 Aug;20(7):470-5. — View Citation
van der Louw EJ, Williams TJ, Henry-Barron BJ, Olieman JF, Duvekot JJ, Vermeulen MJ, Bannink N, Williams M, Neuteboom RF, Kossoff EH, Catsman-Berrevoets CE, Cervenka MC. Ketogenic diet therapy for epilepsy during pregnancy: A case series. Seizure. 2017 Feb;45:198-201. doi: 10.1016/j.seizure.2016.12.019. Epub 2016 Dec 26. — View Citation
Williams TJ, Cervenka MC. The role for ketogenic diets in epilepsy and status epilepticus in adults. Clin Neurophysiol Pract. 2017 Jul 1;2:154-160. doi: 10.1016/j.cnp.2017.06.001. eCollection 2017. Review. — View Citation
Yamanashi T, Iwata M, Kamiya N, Tsunetomi K, Kajitani N, Wada N, Iitsuka T, Yamauchi T, Miura A, Pu S, Shirayama Y, Watanabe K, Duman RS, Kaneko K. Beta-hydroxybutyrate, an endogenic NLRP3 inflammasome inhibitor, attenuates stress-induced behavioral and inflammatory responses. Sci Rep. 2017 Aug 9;7(1):7677. doi: 10.1038/s41598-017-08055-1. — View Citation
Yang X, Cheng B. Neuroprotective and anti-inflammatory activities of ketogenic diet on MPTP-induced neurotoxicity. J Mol Neurosci. 2010 Oct;42(2):145-53. doi: 10.1007/s12031-010-9336-y. Epub 2010 Mar 24. — View Citation
Youm YH, Nguyen KY, Grant RW, Goldberg EL, Bodogai M, Kim D, D'Agostino D, Planavsky N, Lupfer C, Kanneganti TD, Kang S, Horvath TL, Fahmy TM, Crawford PA, Biragyn A, Alnemri E, Dixit VD. The ketone metabolite ß-hydroxybutyrate blocks NLRP3 inflammasome-mediated inflammatory disease. Nat Med. 2015 Mar;21(3):263-9. doi: 10.1038/nm.3804. Epub 2015 Feb 16. — View Citation
* Note: There are 33 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in total blood cholesterol level | Units: milligram/deciliter | At baseline and every 24 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days | |
Other | Change in blood low-density lipoprotein level | Units: milligram/deciliter | At baseline and every 24 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days | |
Other | Change in blood high-density lipoprotein level | Units: milligram/deciliter | At baseline and every 24 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days | |
Other | Change in blood triglycerides level | Units: milligram/deciliter | At baseline and every 24 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days | |
Other | Change in blood glucose level | Glucose: sugar in blood. Units: millimole/liter | At baseline and every 24 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days | |
Other | Change in blood glucagon level | Glucagon: hormone release by pancreas that increase concentration of glucose in blood. Units: nanogram/liter | At baseline and every 24 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days | |
Other | Change in blood free fatty acids level | Free fatty acids are fatty acids that are produced from triglycerides and are measure in blood. | At baseline and every 24 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days | |
Other | Change in blood insulin levels | Hormone that regulates glucose. Units: insulin units/liter | At baseline and every 24 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days | |
Other | Change in blood leptin levels | Leptin helps regulate and alter long-term food intake and energy expenditure. Units: nanogram/deciliter | At baseline and every 24 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days | |
Other | Change in blood insulin like growth factor 1 levels | Units: nanomole/liter | At baseline and every 24 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days | |
Other | Change in blood C-reactive protein levels | C-reactive protein is a protein made by the liver that measures inflammation (e.g. pancreatitis). Units: microgram/milliliter | At baseline and every 24 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days | |
Other | Change in blood interleukin-1ß levels | Cytokines are signaling molecules that measure inflammation. | At baseline and every 24 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days | |
Other | Change in blood interleukin-6 levels | Cytokines are signaling molecules that measure inflammation. | At baseline and every 24 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days | |
Other | Change in blood interleukin-18 levels | Cytokines are signaling molecules that measure inflammation. | At baseline and every 24 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days | |
Other | Change in blood tumor necrosis factor alpha levels | Cytokines are signaling molecules that measure inflammation. | At baseline and every 24 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days | |
Other | Change in blood C-C motif chemokine ligand 2 (CCL2) levels | Chemokine that mediates inflammation. | At baseline and every 24 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days | |
Other | Change in blood C-C motif chemokine ligand 3 (CCL3) levels | Chemokine that mediates inflammation. | At baseline and every 24 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days | |
Other | Change in blood C-C motif chemokine ligand 4 (CCL4) levels | Chemokine that mediates inflammation. | At baseline and every 24 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days | |
Other | Change in blood B cell-attracting chemokine 1 (CXCL13) levels | Chemokine that mediates inflammation. | At baseline and every 24 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days | |
Other | Change in blood ferritin levels | Ferritin stores iron inside of cells. Units: nanogram/milliliter | At baseline and every 24 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days | |
Other | Change in blood betahydroxybutyrate levels | Units: millimole/liter | At baseline and every 24 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days | |
Other | Change in blood urine acetoacetate levels | Units: millimole/liter | At baseline and every 24 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days | |
Primary | Change in the partial pressure of carbon dioxide (PaCO2) | PaCO2 is the partial pressure of carbon dioxide Units: millimeters of mercury | Daily until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days | |
Secondary | Change in minute ventilation | Minute ventilation is the product of respiratory rate and tidal volume. Units: Liter per minute | every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days | |
Secondary | Change in respiratory system compliance | Respiratory system compliance measures the extent to which the lungs will expand. In a ventilated patient, compliance can be measured by dividing the delivered tidal volume by the [plateau pressure minus the total peep]. Units: liter/centimeter of water |
every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days | |
Secondary | Change in driving pressure | Driving pressure is a measure of the strain applied to the respiratory system and the risk of ventilator-induced lung injuries Driving pressure = Plateau pressure - Total Positive end-expiratory pressure (PEEP) Units: centimeter of water | every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days | |
Secondary | Change in ventilator synchrony | Ventilator synchrony is the match between the patient's neural inspiratory time and the ventilator insufflation time | every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days | |
Secondary | Change in mean arterial pressure | Mean arterial pressure is the average pressure in a patient's arteries during one cardiac cycle. Mean arterial pressure = diastolic blood pressure +[1/3(systolic blood pressure - diastolic blood pressure)] Units: millimeter of mercury | every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days | |
Secondary | Change in the fraction of inspired oxygen percentage of oxygen (FiO2) | FiO2: Fraction of Inspired Oxygen Percentage of oxygen in the air mixture that is delivered to the patient. Units: % |
every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days | |
Secondary | Change in the partial pressure of carbon dioxide (PaO2) to the fraction of inspired oxygen percentage of oxygen (FiO2) ratio | PaO2/FiO2 ratio is the ratio of arterial oxygen partial pressure (PaO2) to fractional inspired oxygen. Units: millimeter of mercury |
every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days | |
Secondary | Change in hydrogen ion activity (pH) | pH measures hydrogen ion activity. It is a conventional part of every arterial blood gas determination pH: no units. | every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days | |
Secondary | Change in Bicarbonate (HCO3) | Bicarbonate is a conventional part of every arterial blood gas determination Units: milliequivalents/Liter | every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days | |
Secondary | Change in red blood cell count | Red blood cell count measure anemia or hypoglycemia. Units: cells per liter | every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days | |
Secondary | Change in white blood cell count | White blood cell count evaluates leukopenia or leukocytosis. Units: cells/liter | every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days | |
Secondary | Change in white cell differential | White cell differential shows the amount of neutrophils, lymphocytes, basophils, eosinophils and may give some clue of the type of infection. Units: % | every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days | |
Secondary | Change in hemoglobin levels | Hemoglobin is an indirect way to measure red blood cells. Units: gram/deciliter | every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days | |
Secondary | Change in hematocrit | Hematocrit measures the volume percentage of red blood cells in blood. Units: % | every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days | |
Secondary | Change in mean cell volume | Mean cell volume is a measure of the average volume of a red blood corpuscle. Units: femtoliters | every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days | |
Secondary | Change in mean cell hemoglobin | Mean cell hemoglobin is the average mass of hemoglobin per red blood cell in a sample of blood. Units: picograms | every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days | |
Secondary | Change in mean cell hemoglobin concentration | Mean cell hemoglobin concentration is the average concentration of hemoglobin in a given volume of blood. Units: % | every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days | |
Secondary | Change in platelet count | Platelet count measures the number of platelets in the blood and determines thrombocytopenia or thrombocytosis. Units: platelets/liter | every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days | |
Secondary | Change in red cell distribution width | Red cell distribution width is a measure of the range of variation of red blood cell volume. Units: no units | every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days | |
Secondary | Change in blood albumin level | Liver function test Units: gram/deciliter | every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days | |
Secondary | Change in serum alkaline phosphatase level | Liver function test Units: international units/liter | every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days | |
Secondary | Change in serum aspartate transaminase level | Liver function test Units: international units/liter | every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days | |
Secondary | Change in serum alanine aminotransferase level | Liver function test Units: international units/liters | every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days | |
Secondary | Change in blood urea nitrogen levels | Kidney function test Units: milligram/deciliter | every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days | |
Secondary | Change in serum calcium level | Kidney function test Units: milligram/deciliter | every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days | |
Secondary | Change in serum chloride level | Kidney function test Units: millimole/liter | every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days | |
Secondary | Change in serum potassium level | Kidney function test Units: millimole/liter | every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days | |
Secondary | Change in serum creatinine level | Kidney function test Units: gram/deciliter | every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days | |
Secondary | Date patient is re-intubated or need mechanical ventilation for a second time | If the patient needs mechanical ventilation for a second time, this information will be collected. | Up to 10 days | |
Secondary | Length of intensive care unit stay | Time from intensive care unit admission until death or transfer to hospital bed. | Up to 10 days | |
Secondary | The total hospital stay | Time from hospital admission to discharge from the hospital. This information will be collected. | Up to 10 days | |
Secondary | Disposition at discharge | Once the patient feels better and can leave the hospital, he/she will be discharged. The place of discharge (e.g. home, rehab facility, nursing home, etc), time and date will be collected. | Up to 10 days | |
Secondary | Change in heart rate | Heart rate: is the number of times a person's heart beats per minute | every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days | |
Secondary | Change in the dosage of vasopressor medication | Units: milligram | every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
NCT06065033 -
Exercise Interventions in Post-acute Sequelae of Covid-19
|
N/A | |
Completed |
NCT06267534 -
Mindfulness-based Mobile Applications Program
|
N/A | |
Completed |
NCT05047601 -
A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection
|
Phase 2/Phase 3 | |
Recruiting |
NCT04481633 -
Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection
|
N/A | |
Recruiting |
NCT05323760 -
Functional Capacity in Patients Post Mild COVID-19
|
N/A | |
Completed |
NCT04537949 -
A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults
|
Phase 1/Phase 2 | |
Completed |
NCT04612972 -
Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) to Prevent COVID-19 in Healthy Adult Population In Peru Healthy Adult Population In Peru
|
Phase 3 | |
Recruiting |
NCT05494424 -
Cognitive Rehabilitation in Post-COVID-19 Condition
|
N/A | |
Active, not recruiting |
NCT06039449 -
A Study to Investigate the Prevention of COVID-19 withVYD222 in Adults With Immune Compromise and in Participants Aged 12 Years or Older Who Are at Risk of Exposure to SARS-CoV-2
|
Phase 3 | |
Enrolling by invitation |
NCT05589376 -
You and Me Healthy
|
||
Completed |
NCT05158816 -
Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19
|
||
Recruiting |
NCT04341506 -
Non-contact ECG Sensor System for COVID19
|
||
Completed |
NCT04512079 -
FREEDOM COVID-19 Anticoagulation Strategy
|
Phase 4 | |
Completed |
NCT04384445 -
Zofin (Organicell Flow) for Patients With COVID-19
|
Phase 1/Phase 2 | |
Completed |
NCT05975060 -
A Study to Evaluate the Safety and Immunogenicity of an (Omicron Subvariant) COVID-19 Vaccine Booster Dose in Previously Vaccinated Participants and Unvaccinated Participants.
|
Phase 2/Phase 3 | |
Active, not recruiting |
NCT05542862 -
Booster Study of SpikoGen COVID-19 Vaccine
|
Phase 3 | |
Terminated |
NCT05487040 -
A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease
|
Phase 1 | |
Withdrawn |
NCT05621967 -
Phonation Therapy to Improve Symptoms and Lung Physiology in Patients Referred for Pulmonary Rehabilitation
|
N/A | |
Terminated |
NCT04498273 -
COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80
|
Phase 3 | |
Active, not recruiting |
NCT06033560 -
The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)-Related Hypoxemic Respiratory Failure
|