Trial NCT04739410
Publication Khan Chachar AZ, Int J Sci, 2020 (published paper)
Funding: No specific funding
Conflict of interest: *
Methods | |
RCT Blinding: Unblinded | |
Location :
Single center / Pakistan Follow-up duration (days): 7 | |
Inclusion criteria | - All patients diagnosed with COVID-19 infection with positive reverse transcriptase RT-PCR test, who were willing to participate in this study;
- Patients having age of 18-75 years; - Patients of both genders male and female; - Patients who had mild symptoms of Corona virus disease and RT- PCR positive for SARSCov-2; - Ability to take oral medication and were willing to adhere to the drug intake regimen |
Exclusion criteria | Known severe allergic reactions to Ivermectin;
- Pregnancy or breastfeeding; - Severe symptoms likely attributed to Cytokine Release Storm; - Malignant diseases ; Chronic kidney disease; - Cirrhosis liver with Child class B or C |
Interventions | |
Treatment
Ivermectin 12mg PO followed by 12 mg after 12 hours and 12mg after 24 hours |
|
Control
Standard care Definition of Standard care: symptomatic treatment | |
Participants | |
Randomized 50 participants (n1=25 / n2= 25) | |
Characteristics of participants N=50 Mean age : 41.8 31 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=0 Critical: n=0 | |
Primary outcome | |
In the register 1.Resolution of symptoms [ Time Frame: 7 days ] Will look for resolution of Fever, Fatigue, myalgias, cough and we had an questionaire for that as well and followed up on their chest x rays for progression of the disease Progression of the disease [ Time Frame: 14 days ] did the disease progress from mild to moderate severity, like follow up chest x ray showed more infiltrates or their oxygen saturations in % dropped from their baseline and baseline symptoms persisted and got worse | |
In the report Improvement of symptoms like Fever, Cough, sore throat, Headache, Shortness of breath, lethargy, and fatigue at day 7. | |
Documents available |
Protocol Yes. In English Statistical plan Yes 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 all available versions of the published/pre-print article, the study registry and protocol were used in data extraction and risk of bias assessment. The target sample size specified in the registry was achieved.There is no change from the trial registration in the intervention. The outcome "Progression of the disease [ Time Frame: 14 days ]" was mentioned in the register but not reported.
This study was updated on February 9th, 2021 after contact with authors. |