Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HCQ · 1 trial · 1 indication
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 ...
HCQ is a small molecule being studied for the treatment of Covid-19, a disease caused by the SARS-CoV-2 virus. It is an investigational drug in clinical development for this indication and has not been approved for this use.
HCQ is being developed by Novartis AG, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical research to evaluate the drug's safety and efficacy in patients with Covid-19.
HCQ is in Phase 3 clinical development for Covid-19. This phase typically involves larger studies to confirm the drug's effectiveness, monitor side effects, and compare it to commonly used treatments. The drug remains investigational and is not yet approved.
HCQ has one completed clinical trial registered under NCT04358081, titled "Hydroxychloroquine Monotherapy and in Combination With Azithromycin in Patients With Moderate and Severe COVID-19 Disease." This Phase 3 study enrolled 20 participants in the United States.
HCQ is the abbreviation for hydroxychloroquine, a medication that has been used for other conditions. In the context of Covid-19, it is being investigated as a potential treatment, but it is not approved for this indication and remains in clinical development.