Trial NCT04491994
Publication Kamran S M, Cureus, 2021 (published paper)
Dates: 2020-04-10 to 2020-05-17
Funding: No specific funding (No financial support was received from any organization for the submitted work. )
Conflict of interest: No

Methods
RCT
Blinding: Unblinded
Location : Single center / Pakistan
Follow-up duration (days): 14
Inclusion criteriaMild COVID-19 ; RT-PCR-confirmed infection ; hospital-admitted patients ; 18-80 years of age.
Exclusion criteriaModerate, severe, or critical COVID-19 ; day-zero C-reactive protein (CRP) >6 mg/dl or absolute lymphocyte count (ALC) <1000 ; evidence of infiltrates on X-ray chest ; co-morbidity with life expectancy of less than six months ; contraindications to HCQ therapy.
Interventions
Treatment
Hydroxychloroquine
Initial dose: 400 mg orally twice a day for day 1 - Maintenance dose: 200 mg twice a day for the next five days.
Control
Standard care ( / )
Definition of Standard care: SOC treatment comprised daily oral vitamin C (2 g), oral zinc (50 mg), oral vitamin D (alfacalcidol 1 mcg), and oral acetaminophen (for body aches and fever).
Participants
Randomized
540 participants (n1=360 / n2= 180)
Characteristics of participants
N=540
Mean age : 34
467 males
Severity : Mild: n=500 / Moderate: n=0/ Severe: n=0 Critical: n=0
Primary outcome
In the register
Number of Participants With Progression [ Time Frame: 5 days ]
After start of treatment, development of fever > 101 F for > 72 hours, shortness of breath by minimal exertion (10-Step walk test), derangement of basic lab parameters (ALC < 1000 or raised CRP) or appearance of infiltrates on CXR during course of treatment was labeled as progression irrespective of PCR status.
In the report
Disease progression within five days of start of treatment. Progression of disease was defined by the development of fever >101 F for >72 hours, shortness of breath with minimal exertion, derangement of basic laboratory parameters (ALC < 1000 or raised CRP), or appearance of infiltrates on X-ray chest
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing stated

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
High
General comment In addition to the published article, the retrospective trial registry with results was used in data extraction and assessment of risk of bias. Neither full study protocol nor statistical analysis plan was available. There were no differences between the trial registry and brief protocol and the published article in population, procedures, interventions or outcomes. The study achieved its target sample size. Despite satisfactory randomisation procedure, the study was assessed as being at a high risk of bias due to apparent selection of control participants based on preference and/or contraindications to the study drug (patients who did not give consent for treatment with HCQ or had a known allergy to HCQ or chloroquine or had any other known contraindication to treatment with the study drug served were allocated as controls) and because of some concerns in three of four other domains.