Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04358081 | Hydroxychloroquine Monotherapy and in Combination With Azithromycin in Patients With Moderate and Severe COVID-19 Disease | PHASE3 | COMPLETED | 20 | — | — | May 1, 2020 | Jul 27, 2020 | Oct 11, 2021 | 7 | United States |
Clinical response was defined as a) discharged alive; or b) No need for mechanical ventilation in any participants and no need for supplemental oxygen requirement (SpO2) in participants without pre-morbid O2 requirement.
| Arm | Type | Description |
|---|---|---|
| Arm 1: hydroxychloroquine + aithromycin placebo | EXPERIMENTAL | Hydroxychloroquine 600mg o.d. as loading dose (Day 1) +followed by 200mg t.i.d was initiated within 8-12 hours of the loading dose (not to exceed 12 hours) Azithromycin (AZT) placebo o.d. |
| Arm 2: hydroxychloroquine + azithromycin | EXPERIMENTAL | Hydroxychloroquine 600 mg o.d. as a loading dose (Day 1) followed by 200 mg t.i.d. was initiated within 8-12 hours of the loading dose (not to exceed 12 hours) Azithromycin: 500 mg as a loading dose (Day 1) followed by 250 mg o.d. Day 2 - Day 5 |
| Arm 3: hydroxychloroquine placebo + azithromycin placebo | PLACEBO_COMPARATOR | Hydroxychloroquine placebo o.d. (day 1) followed by hydroxychloroquine placebo t.i.d Azythromycin placebo o.d. |
| Name | Type | Description |
|---|---|---|
| HCQ | DRUG | Hydroxychloroquine Monotherapy |
| HCQ+AZT | DRUG | Hydroxychloroquine with azithromycin |
| Placebo | DRUG | Placebo |
Inclusion Criteria: 1. Informed consent must be obtained prior to participation in the study 2. Adult patient ≥ 18 years old 3. Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test from respiratory tract specimen (e.g nasopharyngeal ...