Trial NCT04434144
Publication Chowdhury ATMM, EJMO, 2021 (published paper)
Dates: 2020-05-02 to 2020-06-05
Funding: No specific funding (Not applicable)
Conflict of interest: No
| Methods | |
| RCT | |
| Location :
Single center / Bangladesh Follow-up duration (days): 35 | |
| Inclusion criteria | Patients (16 years to 80 years of age) tested positive for SARS-CoV-2 infection by Real-time polymerase chain reaction(RT-PCR) at Chakoria Upazilla Health Complex, Cox's Bazar, Bangladesh, from second may to the fifth June 2020, were initially included in this study, including those with and without the 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 Ivermectin: 200 mcg/kg orally once off. Doxycycline: 100 mg orally once a day for 10 days. |
|
| 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=0 / 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 published/pre-print article, 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.
The study was updated on March 26th, 2021 with data from published report. |