Trial NCT04315896
Publication Hernandez-Cardenas C, medRxiv, 2021 (preprint)
Dates: 2020-04-08 to 2020-07-12
Funding: Mixed (Support for the trial was received from the participating hospitals; CONACYT (National Council of Science and Technology of Mexico); SANOFI)
Conflict of interest: *
| Methods | |
| RCT Blinding: quadruple blinding | |
| Location :
Multicenter / Mexico Follow-up duration (days): 30 | |
| Inclusion criteria | 1) Adults over 18 years of age
2) < 14 days from symptoms onset 3) A confirmed diagnosis of COVID-19 by RT-PCR (in a pharyngeal/nasopharyngeal swab sample or in a tracheal aspirate/bronchial lavage) 4) Required hospitalization as decided by the attending physicians. |
| Exclusion criteria | 1) Known previous COVID-19 infection
2) previously treated with HCQ or chloroquine during the last month 3) pregnant woman 4) those with a planned transfer to another hospital unit ; participating in another COVID-19 trial 5) contraindication to start or continue HCQ including known hypersensitivity to HCQ or chloroquine, a corrected QT interval (QTc) >0.50 s, severe liver or kidney disease, a history of pre-existing maculopathy, and to avoid to the extent possible a dangerous prolongation of the QTc and derived complications, those with >11 score points (of a maximum of 21 score points) on a scale assessing the risk of QTc prolongation in hospitalized patients, including age, gender, myocardial infarction or heart failure, sepsis, the use of drugs known to prolong the QTc or diuretics, and hypokalemia. |
| Interventions | |
| Treatment
Hydroxychloroquine 200 mg twice a day for 10 days, orally or by nasogastric tube |
|
| Control
Placebo ( / ) Duration : | |
| Participants | |
| Randomized 214 participants (n1=106 / n2= 108) | |
| Characteristics of participants N=214 Mean age : 49.5 161 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=52 Critical: n=162 | |
| Primary outcome | |
| In the register All-cause hospital mortality [ Time Frame: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 120 days ] | |
| In the report 30-day mortality rate after randomization | |
| Documents avalaible |
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 |
Some concerns |
| General comment |
In addition to the pre-print article, the trial registry was used in data extraction and assessment of risk of bias. Neither study protocol nor statistical analysis plan was available. There were no substantive differences between the registry and the pre-print article in population, procedures, interventions or outcomes. The study was stopped early due to reduced recruitment following the worldwide suspension of several large trials testing HCQ.
Quote: "In mid-July, 2020, the rhythm of recruitment was reduced drastically, due to several reasons including patient refusal, that of their relatives, or that of their treating physicians, coinciding with the worldwide suspension of several large trials testing HCQ in which no benefits of the drug were found. Thus, it became unfeasible to complete the proposed sample size." |