Trial Outcomes & Findings for Maraviroc in Patients With Moderate and Severe COVID-19 (NCT NCT04435522)

NCT ID: NCT04435522

Last Updated: 2024-04-29

Results Overview

Rate of subjects who complete the 7-day course of Maraviroc (or shorter if discharged from hospital prior to 7 days) without discontinuation for serious adverse event or death.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 9 participants
• Primary outcome timeframe: 7 days
• Results posted on: 2024-04-29

Participant Flow

Participant milestones

Measure	Maraviroc Treatment Maraviroc 300 mg Twice Daily Maraviroc: Maraviroc will be administered for seven days. Biomarkers of disease will be checked at time of enrollment, during and at the conclusion of therapy.
Overall Study STARTED	9
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Maraviroc Treatment Maraviroc 300 mg Twice Daily Maraviroc: Maraviroc will be administered for seven days. Biomarkers of disease will be checked at time of enrollment, during and at the conclusion of therapy.
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Maraviroc in Patients With Moderate and Severe COVID-19

Baseline characteristics by cohort

Measure	Maraviroc Treatment n=9 Participants Maraviroc 300 mg Twice Daily Maraviroc: Maraviroc will be administered for seven days. Biomarkers of disease will be checked at time of enrollment, during and at the conclusion of therapy.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants

PRIMARY outcome

Timeframe: 7 days

Population: Patients who received at least one dose of Maraviroc

Rate of subjects who complete the 7-day course of Maraviroc (or shorter if discharged from hospital prior to 7 days) without discontinuation for serious adverse event or death.

Outcome measures

Measure	Maraviroc Treatment n=7 Participants Maraviroc 300 mg Twice Daily Maraviroc: Maraviroc will be administered for seven days. Biomarkers of disease will be checked at time of enrollment, during and at the conclusion of therapy.
Rate of Completion	7 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Maraviroc Treatment n=7 Participants Maraviroc 300 mg Twice Daily Maraviroc: Maraviroc will be administered for seven days. Biomarkers of disease will be checked at time of enrollment, during and at the conclusion of therapy.
Clinical Improvement at Day 7	3 Participants

SECONDARY outcome

Timeframe: 28 days

Population: Population that received at least 1 dose of Maraviroc

7-, 14- and 28-day all-cause-mortality

Outcome measures

Measure	Maraviroc Treatment n=7 Participants Maraviroc 300 mg Twice Daily Maraviroc: Maraviroc will be administered for seven days. Biomarkers of disease will be checked at time of enrollment, during and at the conclusion of therapy.
Mortality 7-Day Mortality	0 Participants
Mortality 14-Day Mortality	0 Participants
Mortality 28-Day Mortality	0 Participants

SECONDARY outcome

Timeframe: 28 Days

If no clinical improvement of >=2 points met by day 28, patient outcome censored

Outcome measures

Measure	Maraviroc Treatment n=7 Participants Maraviroc 300 mg Twice Daily Maraviroc: Maraviroc will be administered for seven days. Biomarkers of disease will be checked at time of enrollment, during and at the conclusion of therapy.
Median Time to >= 2 Point Improvement in Clinical Score.	8 Days Interval 5.0 to 28.0

Adverse Events

Maraviroc Group

Serious events: 1 serious events

Other events: 1 other events

Deaths: 2 deaths

Serious adverse events

Measure	Maraviroc Group n=9 participants at risk Single-arm group receiving Maraviroc for 7 days.
Cardiac disorders Death	11.1% 1/9 • Number of events 1 • Adverse event data was collected over 35 days from day of enrollement.

Other adverse events

Measure	Maraviroc Group n=9 participants at risk Single-arm group receiving Maraviroc for 7 days.
Gastrointestinal disorders Nausea	11.1% 1/9 • Number of events 1 • Adverse event data was collected over 35 days from day of enrollement.
Gastrointestinal disorders Transaminitis	11.1% 1/9 • Number of events 1 • Adverse event data was collected over 35 days from day of enrollement.

Additional Information

Philip Chan, M.D.

Rhode Island Hospital

Phone: 401-793-4859

Email: philip_chan@brown.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place