Safety and Efficacy of Ivermectin and Doxycycline in Treatment of Covid-19

• Status: Not yet recruiting
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

A randomized double blind control trial will be done. Total 188 Covid-19 patients will be enrolled in this trial who are RT-PCR confirmed case of mild cases. Before enrollment, base line investigations will be done and as per eligibility criteria 188 (one hundred eighty eight) patients of mild symptoms will be selected by random sampling. Ninety four diagnosed patients (Group-A) of Covid-19 will be in the experimental group and 94 Covid-19 diagnosed patients (Group-B) will be in the control group.

Group -A will be given combination treatment of Tab Ivermectin and Cap Doxycycline along with standard therapy and Group -B will be treated by standard therapy with placebo.

Follow up will be done every day in both group with all the parameters as stated above and will be documented.

On 5th day of treatment, if fever subsides final outcome will be measured by result of RT-PCR test preferably from one designated lab with sample of nasal swab for all. Subject to RT-PCR test negative result again on 6th day another RT-PCR test will be done at 24 hours apart. But if RT-PCR test result remain positive on 5th day, again on 10th day same test is to be done and also on 11th day subject to test result as negative on 10th day.

Death of the patients will be documented as well. Regarding safety issues of the drugs we shall monitor for any SAE and would report to the DSMB for proper management guideline

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bangladesh Medical Research Council (BMRC)
• Treatments: Doxycycline; Ivermectin

Criteria

Inclusion Criteria:

• Subjects within age group 18 years to onward

• With either sex, male or female

• Confirmed mild cases of Covid-19 by RT-PCR test

• patients who are classified as mild cases with typical symptoms

• patients who are not already treated with any other antiviral drugs

Exclusion Criteria:

• Patients who are asymptomatic,moderate, severe and critically ill (resting respiratory rate more than 30, O2 saturation below 93%).

• Patients with co-morbidities (diabetes, hypertension, chronic liver and kidney diseases obesity, pre-existing ischemic heart disease, COPD,other severe disease)

• Patients with pregnancy and on lactation

• Patients with previous allergic reaction to Ivermectin or Doxycycline