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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04355247
Other study ID # CCAM 20-01
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date April 14, 2020
Est. completion date April 30, 2021

Study information

Verified date April 2020
Source Auxilio Mutuo Cancer Center
Contact Fernando Cabanillas, MD
Phone 787-758-2000
Email cabanillasmd@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a Phase II pilot exploratory study designed to investigate if prophylactic treatment with short term steroids administered to high risk Covid-19 patient might prevent cytokine storm and progression to respiratory failure. High risk is defined based on serologic markers of inflammation that include abnormalities of Interleukin 6 (IL-6), Ferritin , D-dimer, Lactate Dehydrogenase (LDH), as well as lymphopenia and impaired O2 saturation prior to or on the 7th day of first symptom of Covid-19.


Description:

To decrease the rate of progression to hypoxemic respiratory failure in high risk patients with Covid-19, treated with prophylactic steroids during the first phase of the disease.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date April 30, 2021
Est. primary completion date July 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- All patients diagnosed with Covid-19 will be registered on the study regardless pf their severity, but only those who meet high risk criteria will be treated with steroids. Those who don't meet the criteria will only be registered with no need to collect further data except baseline labs and CT Chest. They should sign the consent form and the data manager can collect the rest of the information.

- Patients older than 18 years diagnosed with Covid-19 by Polymerase Chain Reaction (PCR) or by rapid serological test will be eligible. Cases who are Immunoglobulin G (IgG) positive but Immunoglobulin M (IgM) negative, will not be considered eligible unless they are positive for molecular PCR test. Eligible patients will be registered on study on or before 7 days from first onset of symptoms.

Exclusion Criteria:

- Any patient with life expectancy < 1 month

- Any patient who is oxygen dependent

- Any patient with long standing history of severe Chronic Obstructive Pulmonary Disease (COPD)

- Any patient who is chronically oxygen dependent because of previous existing lung disease

- Anyone with severely uncontrolled diabetes despite adequate management

- Anyone with active serious bacterial infection such as septicemia or pneumonia

- Anyone receiving Tocilizumab (anti IL-6 therapy) or plasma therapy

- Any patient already receiving steroids from another pre-existing illness

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
MethylPREDNISolone 80 Mg/mL Injectable Suspension
Patients will be admitted to a regular room in the hospital (not ICU) They will be monitored closely with vital signs every 4 hours to ensure their respiratory and cardiovascular status do not deteriorate. Methylprednisolone 80 mg IV bolus injection will be given daily x 5 days starting upon day 1 of admission to hospital.

Locations

Country Name City State
Puerto Rico Hospital Auxilio Mutuo Cancer Center San Juan
Puerto Rico San Juan City Hospital / Puerto Rico Medical Center San Juan

Sponsors (1)

Lead Sponsor Collaborator
Auxilio Mutuo Cancer Center

Country where clinical trial is conducted

Puerto Rico, 

References & Publications (8)

Carr AC. A new clinical trial to test high-dose vitamin C in patients with COVID-19. Crit Care. 2020 Apr 7;24(1):133. doi: 10.1186/s13054-020-02851-4. — View Citation

Chen L, Xiong J, Bao L, Shi Y. Convalescent plasma as a potential therapy for COVID-19. Lancet Infect Dis. 2020 Apr;20(4):398-400. doi: 10.1016/S1473-3099(20)30141-9. Epub 2020 Feb 27. — View Citation

Gautret P, Lagier JC, Parola P, Hoang VT, Meddeb L, Mailhe M, Doudier B, Courjon J, Giordanengo V, Vieira VE, Dupont HT, Honoré S, Colson P, Chabrière E, La Scola B, Rolain JM, Brouqui P, Raoult D. Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial. Int J Antimicrob Agents. 2020 Mar 20:105949. doi: 10.1016/j.ijantimicag.2020.105949. [Epub ahead of print] — View Citation

Grein J, Ohmagari N, Shin D, Diaz G, Asperges E, Castagna A, Feldt T, Green G, Green ML, Lescure FX, Nicastri E, Oda R, Yo K, Quiros-Roldan E, Studemeister A, Redinski J, Ahmed S, Bernett J, Chelliah D, Chen D, Chihara S, Cohen SH, Cunningham J, D'Arminio Monforte A, Ismail S, Kato H, Lapadula G, L'Her E, Maeno T, Majumder S, Massari M, Mora-Rillo M, Mutoh Y, Nguyen D, Verweij E, Zoufaly A, Osinusi AO, DeZure A, Zhao Y, Zhong L, Chokkalingam A, Elboudwarej E, Telep L, Timbs L, Henne I, Sellers S, Cao H, Tan SK, Winterbourne L, Desai P, Mera R, Gaggar A, Myers RP, Brainard DM, Childs R, Flanigan T. Compassionate Use of Remdesivir for Patients with Severe Covid-19. N Engl J Med. 2020 Apr 10. doi: 10.1056/NEJMoa2007016. [Epub ahead of print] — View Citation

Russell CD, Millar JE, Baillie JK. Clinical evidence does not support corticosteroid treatment for 2019-nCoV lung injury. Lancet. 2020 Feb 15;395(10223):473-475. doi: 10.1016/S0140-6736(20)30317-2. Epub 2020 Feb 7. — View Citation

Wu C, Chen X, Cai Y, Xia J, Zhou X, Xu S, Huang H, Zhang L, Zhou X, Du C, Zhang Y, Song J, Wang S, Chao Y, Yang Z, Xu J, Zhou X, Chen D, Xiong W, Xu L, Zhou F, Jiang J, Bai C, Zheng J, Song Y. Risk Factors Associated With Acute Respiratory Distress Syndrome and Death in Patients With Coronavirus Disease 2019 Pneumonia in Wuhan, China. JAMA Intern Med. 2020 Mar 13. doi: 10.1001/jamainternmed.2020.0994. [Epub ahead of print] — View Citation

Zhang C, Wu Z, Li JW, Zhao H, Wang GQ. The cytokine release syndrome (CRS) of severe COVID-19 and Interleukin-6 receptor (IL-6R) antagonist Tocilizumab may be the key to reduce the mortality. Int J Antimicrob Agents. 2020 Mar 29:105954. doi: 10.1016/j.ijantimicag.2020.105954. [Epub ahead of print] — View Citation

Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11. Erratum in: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical complete response criteria Clinical complete response criteria requires all the following:
No need for ventilatory support at any point
O2 Saturation of >/= 93% by day 14 of therapy
Alive by day 28 from registration
CT chest with minimal or no evidence of disease by day 28 from registration
14 days
Primary Clinical Partial Response criteria Clinical Partial Response criteria require that 2 of the following be present by day 14 of therapy:
No need for ventilatory support at any point O2 saturation > 93% bay day 14 from registration
CT chest stable to improve over baseline by day 28 from registration
14 days
Secondary Secondary response criteria Decrease of at least 25% in anyone of the following markers: IL-6, Ferritin, D-dimer, C reactive protein (CRP) or LDH by day 14
- Improvement of absolute lymphocyte count in those presenting with lymphopenia. Improvement is defined as increase by 25% or more by day 14.
14 days
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