Phase 3
Completed N=479
Outcomes Related to COVID-19 Treated With Hydroxychloroquine Among In-patients With Symptomatic Disease
Coronavirus · Respiratory Disease · SARS-CoV Infection
Source: ClinicalTrials.gov NCT04332991 ↗
Enrolled (actual)
479
Serious AEs
5.2%
Results posted
Mar 2021
Primary outcomePrimary: COVID Outcomes Scale Score on Study Day 15 (14 Days After Randomization) — 6; 6 score on a scale
◆ Published Evidence
Highly cited
430citations · ~72 / year
Effect of Hydroxychloroquine on Clinical Status at 14 Days in Hospitalized Patients With COVID-19: A Randomized Clinical Trial.
Summary
ORCHID is a multicenter, blinded, placebo-controlled, randomized clinical trial evaluating hydroxychloroquine for the treatment of adults hospitalized with COVID-19. Patients, treating clinicians, and study personnel will all be blinded to study group assignment.
Linked Publications (2)
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Effect of Hydroxychloroquine on Clinical Status at 14 Days in Hospitalized Patients With COVID-19: A Randomized Clinical Trial.
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Rationale and Design of ORCHID: A Randomized Placebo-controlled Clinical Trial of Hydroxychloroquine for Adults Hospitalized with COVID-19.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY COVID Outcomes Scale Score on Study Day 15 (14 Days After Randomization) |
6; 6 | — |
| SECONDARY COVID Ordinal Outcomes Scale on Study Day 3 (2 Days After Randomization) |
4; 4 | — |
| SECONDARY COVID Ordinal Outcomes Scale on Study Day 8 (7 Days After Randomization) |
5; 6 | — |
| SECONDARY COVID Ordinal Outcomes Scale on Study Day 29 (28 Days After Randomization) |
6; 6 | — |
| SECONDARY All-location, All-cause Mortality Assessed on Study Day 15 (14 Days After Randomization) |
18; 14 | — |
| SECONDARY All-location, All-cause Mortality Assessed on Study Day 29 (28 Days After Randomization) |
25; 25 | — |
| SECONDARY Number of Patients Dead or With Receipt of ECMO Between Enrollment and Day 28 |
29; 28 | — |
| SECONDARY Oxygen-free Days Through Day 28 |
21; 20 | — |
| SECONDARY Ventilator-free Days Through Day 28 |
28; 28 | — |
| SECONDARY Vasopressor-free Days Through Day 28 |
28; 28 | — |
| SECONDARY ICU-free Days to Day 28 |
28; 28 | — |
| SECONDARY Hospital-free Days to Day 28 |
21; 20 | — |
Eligibility Criteria
Inclusion Criteria
- Age ≥18 years
- Currently hospitalized or in an emergency department with anticipated hospitalization.
- Symptoms of acute respiratory infection, defined as one or more of the following:
- cough
- fever (> 37.5° C / 99.5° F)
- shortness of breath (operationalized as any of the following: subjective shortness of breath reported by patient or surrogate; tachypnea with respiratory rate ≥22 /minute; hypoxemia, defined as SpO2 10 days before randomization
- >48 hours between meeting inclusion criteria and randomization
- Seizure disorder
- Porphyria cutanea tarda
- Diagnosis of Long QT syndrome
- QTc >500 ms on electrocardiogram within 72 hours prior to enrollment
- Known allergy to hydroxychloroquine, chloroquine, or amodiaquine
- Receipt in the 12 hours prior to enrollment, or planned administration during the 5-day study period that treating clinicians feel cannot be substituted for another medication, of any of the following: amiodarone; cimetidine; dofetilide; phenobarbital; phenytoin; sotalol
- Receipt of >1 dose of hydroxychloroquine or chloroquine in the 10 days prior to enrollment
- Inability to receive enteral medications
- Refusal or inability to be contacted on Day 15 for clinical outcome assessment if discharged prior to day 15
- Previous enrollment in this trial
- The treating clinical team does not believe equipoise exists regarding the use of hydroxychloroquine for the treatment of this patient
Data sourced from ClinicalTrials.gov (NCT04332991) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.