Study of the Treatment and Outcomes in Critically Ill Patients With COVID-19

Coronavirus Infection Clinical Trial

— STOP-COVID  

Official title:

Study of the Treatment and Outcomes in Critically Ill Patients With COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04343898
• Other study ID #: 2007P000003
• Status: Completed
• Start date: April 1, 2020
• Est. completion date: July 1, 2023

Study information

• Verified date: August 2023
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Multicenter observational/registry study of the clinical features and outcomes of critically ill patients with COVID-19.

Description:

The goals of this project are to determine the independent risk factors for hospital mortality and acute organ injury, and to identify treatment strategies associated with improved survival. Additionally, we will assess outcomes according to differences in geographic and institutional parameters.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5154
• Est. completion date: July 1, 2023
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria (each of the following):

1. Adults (aged =18 years)

2. Laboratory-confirmed diagnosis of COVID-19

3. Hospitalized in the ICU for illness related to COVID-19

Exclusion Criteria:

-None

Related Conditions & MeSH terms

• Coronavirus Infection
• Coronavirus Infections

Intervention

Other:
• No intervention
Observational

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (52)

Lead Sponsor

Collaborator

Brigham and Women's Hospital

Baylor College of Medicine, Baylor Health Care System, Beth Israel Deaconess Medical Center, Cook County Hospital, Duke University, Georgetown University, Hackensack Meridian Health, Hackensack mountainside hospital, Icahn School of Medicine at Mount Sinai, Indiana University Health Methodist Hospital, Johns Hopkins University, Loma Linda University, Mayo Clinic, Medical College of Wisconsin, Montefiore Medical Center, New Jersey Medical School, Northwestern, NYU Langone Health, Ochsner Health System, Oregon Health and Science University, Renown Health, Rush University Medical Center, Rutgers Robert Wood Johnson Medical School, Stanford University, Temple University, The Cooper Health System, Tufts Medical Center, Tulane University, University Hospitals Cleveland Medical Center, University Medical Center of Southern Nevada, University of Alabama at Birmingham, University of California, Davis, University of California, Los Angeles, University of California, San Diego, University of California, San Francisco, University of Chicago, University of Colorado, Denver, University of Florida, University of Illinois at Chicago, University of Kentucky, University of Miami, University of Michigan, University of North Carolina, Chapel Hill, University of Oklahoma, University of Pennsylvania, University of Pittsburgh Medical Center, University of Tennessee, University of Texas, Southwestern Medical Center at Dallas, University of Washington, Weill Medical College of Cornell University, Yale University

Country where clinical trial is conducted

United States, 

References & Publications (26)

Al-Samkari H, Gupta S, Leaf RK, Wang W, Rosovsky RP, Brenner SK, Hayek SS, Berlin H, Kapoor R, Shaefi S, Melamed ML, Sutherland A, Radbel J, Green A, Garibaldi BT, Srivastava A, Leonberg-Yoo A, Shehata AM, Flythe JE, Rashidi A, Goyal N, Chan L, Mathews KS — View Citation

Churpek MM, Gupta S, Spicer AB, Hayek SS, Srivastava A, Chan L, Melamed ML, Brenner SK, Radbel J, Madhani-Lovely F, Bhatraju PK, Bansal A, Green A, Goyal N, Shaefi S, Parikh CR, Semler MW, Leaf DE; STOP-COVID Investigators. Machine Learning Prediction of — View Citation

Churpek MM, Gupta S, Spicer AB, Parker WF, Fahrenbach J, Brenner SK, Leaf DE; STOP-COVID Investigators. Hospital-Level Variation in Death for Critically Ill Patients with COVID-19. Am J Respir Crit Care Med. 2021 Aug 15;204(403-411):403-11. doi: 10.1164/r — View Citation

Douin DJ, Shaefi S, Brenner SK, Gupta S, Park I, Wright FL, Mathews KS, Chan L, Al-Samkari H, Orfanos S, Radbel J, Leaf DE. Tissue Plasminogen Activator in Critically Ill Adults with COVID-19. Ann Am Thorac Soc. 2021 Nov;18(11):1917-1921. doi: 10.1513/Ann — View Citation

Easter SR, Gupta S, Brenner SK, Leaf DE. Outcomes of Critically Ill Pregnant Women with COVID-19 in the United States. Am J Respir Crit Care Med. 2021 Jan 1;203(1):122-125. doi: 10.1164/rccm.202006-2182LE. No abstract available. — View Citation

Flythe JE, Assimon MM, Tugman MJ, Chang EH, Gupta S, Shah J, Sosa MA, Renaghan AD, Melamed ML, Wilson FP, Neyra JA, Rashidi A, Boyle SM, Anand S, Christov M, Thomas LF, Edmonston D, Leaf DE; STOP-COVID Investigators. Characteristics and Outcomes of Indivi — View Citation

Friedman AN, Guirguis J, Kapoor R, Gupta S, Leaf DE, Timsina LR; STOP-COVID Investigators. Obesity, inflammatory and thrombotic markers, and major clinical outcomes in critically ill patients with COVID-19 in the US. Obesity (Silver Spring). 2021 Oct;29(1 — View Citation

Green A, Rachoin JS, Schorr C, Dellinger P, Casey JD, Park I, Gupta S, Baron RM, Shaefi S, Hunter K, Leaf DE; STOP-COVID Investigators. Timing of invasive mechanical ventilation and death in critically ill adults with COVID-19: A multicenter cohort study. — View Citation

Gupta S, Coca SG, Chan L, Melamed ML, Brenner SK, Hayek SS, Sutherland A, Puri S, Srivastava A, Leonberg-Yoo A, Shehata AM, Flythe JE, Rashidi A, Schenck EJ, Goyal N, Hedayati SS, Dy R, Bansal A, Athavale A, Nguyen HB, Vijayan A, Charytan DM, Schulze CE, — View Citation

Gupta S, Hayek SS, Wang W, Chan L, Mathews KS, Melamed ML, Brenner SK, Leonberg-Yoo A, Schenck EJ, Radbel J, Reiser J, Bansal A, Srivastava A, Zhou Y, Sutherland A, Green A, Shehata AM, Goyal N, Vijayan A, Velez JCQ, Shaefi S, Parikh CR, Arunthamakun J, A — View Citation

Gupta S, Wang W, Hayek SS, Chan L, Mathews KS, Melamed ML, Brenner SK, Leonberg-Yoo A, Schenck EJ, Radbel J, Reiser J, Bansal A, Srivastava A, Zhou Y, Finkel D, Green A, Mallappallil M, Faugno AJ, Zhang J, Velez JCQ, Shaefi S, Parikh CR, Charytan DM, Atha — View Citation

Hayek SS, Brenner SK, Azam TU, Shadid HR, Anderson E, Berlin H, Pan M, Meloche C, Feroz R, O'Hayer P, Kaakati R, Bitar A, Padalia K, Perry D, Blakely P, Gupta S, Shaefi S, Srivastava A, Charytan DM, Bansal A, Mallappallil M, Melamed ML, Shehata AM, Sunder — View Citation

Hsu CM, Gupta S, Tighiouart H, Goyal N, Faugno AJ, Tariq A, Raichoudhury R, Sharma JH, Meyer L, Kshirsagar RK, Jose A, Leaf DE, Weiner DE; STOP-COVID Investigators. Kidney Recovery and Death in Critically Ill Patients With COVID-19-Associated Acute Kidney — View Citation

Jezmir JL, Bharadwaj M, Chaitoff A, Diephuis B, Crowley CP, Kishore SP, Goralnick E, Merriam LT, Milliken A, Rhee C, Sadovnikoff N, Shah SB, Gupta S, Leaf DE, Feldman WB, Kim EY; STOP-COVID Investigators. Performance of crisis standards of care guidelines — View Citation

Keene AB, Admon AJ, Brenner SK, Gupta S, Lazarous D, Leaf DE, Gershengorn HB; STOP-COVID Investigators. Association of Surge Conditions with Mortality Among Critically Ill Patients with COVID-19. J Intensive Care Med. 2022 Apr;37(4):500-509. doi: 10.1177/ — View Citation

Leaf RK, Al-Samkari H, Brenner SK, Gupta S, Leaf DE. ABO phenotype and death in critically ill patients with COVID-19. Br J Haematol. 2020 Aug;190(4):e204-e208. doi: 10.1111/bjh.16984. Epub 2020 Jul 30. No abstract available. — View Citation

Mathews KS, Soh H, Shaefi S, Wang W, Bose S, Coca S, Gupta S, Hayek SS, Srivastava A, Brenner SK, Radbel J, Green A, Sutherland A, Leonberg-Yoo A, Shehata A, Schenck EJ, Short SAP, Hernan MA, Chan L, Leaf DE; STOP-COVID Investigators. Prone Positioning an — View Citation

Merriam LT, Bharadwaj M, Jezmir JL, Leaf DE, Kim EY. Protocol to assess performance of crisis standards of care guidelines for clinical triage. STAR Protoc. 2021 Dec 17;2(4):100943. doi: 10.1016/j.xpro.2021.100943. Epub 2021 Nov 10. — View Citation

Molnar MZ, Bhalla A, Azhar A, Tsujita M, Talwar M, Balaraman V, Sodhi A, Kadaria D, Eason JD, Hayek SS, Coca SG, Shaefi S, Neyra JA, Gupta S, Leaf DE, Kovesdy CP; STOP-COVID Investigators. Outcomes of critically ill solid organ transplant patients with CO — View Citation

Ricardo AC, Chen J, Toth-Manikowski SM, Meza N, Joo M, Gupta S, Lazarous DG, Leaf DE, Lash JP; STOP-COVID Investigators. Hispanic ethnicity and mortality among critically ill patients with COVID-19. PLoS One. 2022 May 18;17(5):e0268022. doi: 10.1371/journ — View Citation

Shaefi S, Brenner SK, Gupta S, O'Gara BP, Krajewski ML, Charytan DM, Chaudhry S, Mirza SH, Peev V, Anderson M, Bansal A, Hayek SS, Srivastava A, Mathews KS, Johns TS, Leonberg-Yoo A, Green A, Arunthamakun J, Wille KM, Shaukat T, Singh H, Admon AJ, Semler — View Citation

Short SAP, Gupta S, Brenner SK, Hayek SS, Srivastava A, Shaefi S, Singh H, Wu B, Bagchi A, Al-Samkari H, Dy R, Wilkinson K, Zakai NA, Leaf DE; STOP-COVID Investigators. d-dimer and Death in Critically Ill Patients With Coronavirus Disease 2019. Crit Care — View Citation

Sunderraj A, Cho C, Cai X, Gupta S, Mehta R, Isakova T, Leaf DE, Srivastava A; STOP-COVID Investigators. Modulation of the Association Between Age and Death by Risk Factor Burden in Critically Ill Patients With COVID-19. Crit Care Explor. 2022 Aug 29;4(9) — View Citation

Toth-Manikowski SM, Caldwell J, Joo M, Chen J, Meza N, Bruinius J, Gupta S, Hannan M, Kagalwalla M, Madrid S, Melamed ML, Pacheco E, Srivastava A, Viamontes C, Lash JP, Leaf DE, Ricardo AC; STOP-COVID Investigators. Sex-related differences in mortality, a — View Citation

Vasbinder A, Meloche C, Azam TU, Anderson E, Catalan T, Shadid H, Berlin H, Pan M, O'Hayer P, Padalia K, Blakely P, Khaleel I, Michaud E, Huang Y, Zhao L, Pop-Busui R, Gupta S, Eagle K, Leaf DE, Hayek SS; STOP-COVID Investigatorsdouble dagger. Relationshi — View Citation

Vasquez CR, Gupta S, Miano TA, Roche M, Hsu J, Yang W, Holena DN, Reilly JP, Schrauben SJ, Leaf DE, Shashaty MGS; STOP-COVID Investigators. Identification of Distinct Clinical Subphenotypes in Critically Ill Patients With COVID-19. Chest. 2021 Sep;160(3): — View Citation

* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28-Day Mortality		28-days from the day of ICU admission
Secondary	60-Day Mortality		60-days from the day of ICU admission
Secondary	90-Day Mortality		90-days from the day of ICU admission