Trial NCT04446104
Publication Seet R
Dates: 5/18/2020 to 6/1/2020
Funding: Mixed (National Medical Research Council; Temasek Foundation; Singapore Millennium Foundation; National University Hospital Research Office. Temasek Foundation (philanthropic), Mundipharma Pte Ltd and Blackmores Ltd donated study drugs. )
Conflict of interest:
Methods | |
RCT | |
Location :
Single center / Singapore Follow-up duration (days): 42 | |
Inclusion criteria | All dormitory residents aged between 21 and 60 who were willing to adhere to the study protocol, return for a review 42-days later, and provide daily symptom feedback through a mobile application, were invited to participate in this trial. |
Exclusion criteria | Symptom(s) of respiratory illnesses (fever, cough, runny nose, sore throat and/or shortness of breath), dysgeusia or anosmia in the past one month; had a previous diagnosis of COVID-19; or met other exclusion criteria (Supplementary Materials[not available] |
Interventions | |
Treatment 1 Hydroxychloroquine | |
Control Vitamin C | |
Treatment 3 Ivermectin | |
Treatment 4 Povidone iodine | |
Treatment 5 Zinc oxide+Vitamin C | |
Participants | |
Randomized 3358 participants n1=481/ n2=663/ n3=709/ n4=863n5=692 | |
Characteristics of participants N=3358 Mean age : 32.6 3037 males | |
Primary outcome | |
In the register Laboratory-confirmed COVID-19 in treatment arms (hydroxychloroquine, ivermectin, zinc and povidone iodine) [ Time Frame: At the end of study dosing, which is day 42 ] | |
In the report | |
Documents available |
Protocol No Statistical plan No 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 and supplemetal material were used in data extraction and assessment of risk of bias. Neither study protocol nor statistical analysis plan was available. At the time of trial registration, there were no approved serological tests for confirmation of SARS-CoV-2 infection. When these became available, the main secondary endpoint was upgraded to the primary endpoint to replace symptom-based endpoints. |