Covid-19 Living Data

Trial NCT04332991
Publication ORCHID - Self W, JAMA (2020) (published paper)
Dates: 2020-04-02 to 2020-06-19
Funding: Mixed (National Heart, Lung, and Blood Institute (NHLBI), NCATS, Harvard Catalyst, Sandoz.)
Conflict of interest: Yes

Methods
	RCT Blinding: Participants, outcome assessor and health care pro
	Location : Multicenter / USA Follow-up duration (days): 28
Inclusion criteria	Age ≥18 year 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 <92% on room air, new receipt of supplemental oxygen to maintain SpO2 ≥92%, or increased supplemental oxygen to maintain SpO2 ≥92% for a patient on chronic oxygen therapy), sore throat Laboratory-confirmed SARS-CoV-2 infection within the past 10 days prior to randomization.
Exclusion criteria	Prisoner Pregnancy Breast feeding Symptoms of acute respiratory infection for >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.
Interventions
	Treatment Hydroxychloroquine 400 mg orally twice daily for first 2 doses, then 200 mg twice daily for subsequent 8 doses for a total of 10 doses over 5 days
	Control Placebo
Participants
	Randomized participants : Hydroxychloroquine=242 Placebo=237
	Characteristics of participants N= 479 Mean age : NR 267 males Severity : Mild: n=168 / Moderate: n=224 / Severe: n=55 Critical: n=32 Number of vaccinated participants: NR
Primary outcome
	In the register COVID Ordinal Outcomes Scale on Day 15 [ Time Frame: assessed on study day 15 ] We will determine the COVID Ordinal Scale for all patients on study day 15
	In the report Clinical status 14 days after randomization assessed with a 7-category ordinal scale (the COVID Outcomes Scale) recommended by the World Health Organization.
Documents available	Protocol Yes. In English Statistical plan Yes Data-sharing willing stated in the publication: Yes
Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review	Some concerns
General comment	In addition to the published article, the trial registry, published design and rationale article, study protocol and statistical analysis plan were used in data extraction and assessment of risk of bias. There were no differences between trial registry, study protocol and published article in terms of population, procedures, treatments or outcomes. The trial was stopped at the fourth interim analysis due to probable futility, announcements of no benefit from the RECOVERY trial in the UK, and advisories from national regulatory agencies.