Maraviroc in Patients With Moderate and Severe COVID-19
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|ClinicalTrials.gov Identifier: NCT04435522|
Recruitment Status : Not yet recruiting
First Posted : June 17, 2020
Last Update Posted : July 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|COVID||Drug: Maraviroc||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open-Label Study of Maraviroc in Hospitalized Individuals Diagnosed With SARS-CoV-2|
|Estimated Study Start Date :||September 2020|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: Maraviroc Treatment
Maraviroc 300 mg Twice Daily
Maraviroc will be administered for seven days. Biomarkers of disease will be checked at time of enrollment, during and at the conclusion of therapy. The cytokine panel will consist of CCL5, IL-6, and Chitinase 3-like 1(Chi3l1).
- Rate of Completion [ Time Frame: 7 days ]Rate of subjects who complete the 7-day course of Maraviroc without discontinuation for serious adverse event or death.
- Clinical improvement at Day 7 [ Time Frame: 7 days ]
Percent of patients at Day 7 from enrollment achieving reduction of two points on a seven-category ordinal scale (defined below).
Ordinal scale: 1, not hospitalized with resumption of normal activities; 2, not hospitalized, but unable to resume normal activities OR hospitalized pending disposition, not requiring COVID-related care; 3, hospitalized, not requiring supplemental oxygen; 4, hospitalized, requiring supplemental oxygen; 5, hospitalized, requiring nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both; 6, hospitalized, requiring ECMO, invasive mechanical ventilation, or both; and, 7, death.
- Change in Chitinase 3-like 1(Chi3l1) (ng/mL) [ Time Frame: 7 days ]Measurement of Chi3l1 before, during and at completion of therapy.
- Change in Interleukin-6 (IL-6) (pg/mL) [ Time Frame: 7 Days ]Measurement of IL-6 before, during and at completion of therapy.
- Change in CCL5 (RANTES) (ng/mL) [ Time Frame: 7 Days ]Measurement of CCL5 before, during and at completion of therapy.
- Mortality [ Time Frame: 28 days ]7-, 14- and 28-day all-cause-mortality
- Time to Discharge [ Time Frame: 28 days ]Time to improvement to Score of 2 or less (Days)
- Days on mechanical ventilation [ Time Frame: 28 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04435522
|Contact: Neel S Belani, MDfirstname.lastname@example.org|
|Contact: Anshul Parulkar, MDemail@example.com|
|United States, Rhode Island|
|Rhode Island Hospital|
|Providence, Rhode Island, United States, 02908|
|Principal Investigator:||Philip A Chan, MD||Warren Alpert Medical School and School of Public Health, Brown University|