Trial NCT04434144
Publication Chowdhury ATMM, Research Square, 2020 (preprint)
Dates: 2020-05-02 to 2020-06-05
Funding: No specific funding (Not applicable)
Conflict of interest: No
Methods | |
RCT Blinding: | |
Location :
Single center / Bangladesh Follow-up duration (days): 35 | |
Inclusion criteria | All patients who tested positive for SARS-CoV-2 infection by RT PCR at Chakoria Upazilla Health Complex, Cox's Bazar; Bangladesh from May 2nd to June 5th, 2020 were initially included in this study, including those with and without symptoms... Patients were all examined with a pulse oximeter and only those with normal oxygen saturation of 95% or above were included. Patients with respiratory symptoms received chest radiograph and only those with normal or near-normal chest radiograph were included. |
Exclusion criteria | Patients with unstable comorbid conditions like bronchial asthma, COPD, ischemic heart disease, uncontrolled diabetes mellitus, advanced renal and hepatic disease, carcinoma, hospitalized, and Immuno-compromised patients |
Interventions | |
Treatment
Ivermectin+Doxycycline (200 mcg/kg/100 mg) Co-Intervention: Standard care Duration : Once-off+10 day |
|
Control
Hydroxychloroquine+Azithromycin (200 mg/500 mg) Duration : 10 days+5 days | |
Participants | |
Randomized 125 participants (n1=63 / n2= 62) | |
Characteristics of participants N=125 Mean age : 33.8 90 males Severity : Mild: n=116 / Moderate: n=0/ Severe: n=0 Critical: n=0 | |
Primary outcome | |
In the register Number of participants with | |
In the report Negative PCR and resolution of symptoms | |
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 |
High |
General comment | In addition to the pre-print, the trial registry was also used in data extraction and risk of bias assessment. The trial was registered as an observational study and retrospectively after enrollment was already completed. Outcomes not registered were reported in the article. There is no change from the trial registration in the intervention and control treatments. |