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

September 15, 2020 updated by: Bangladesh Medical Research Council (BMRC)

The Safety and Efficacy Outcome of Ivermectin Plus Doxycycline in Treatment of RT-PCR Positive Adult Mild Covid-19 Cases: a Randomized Double Blind Placebo Controlled Trial

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

After six weeks of recovery one of our research staff will contact the patient over phone to know about his/her recent health condition.

Randomization will be done by online software "Sealed Envelope" by using computer. Necessary inputs will be given to the software regarding sample size, number of sets and number of blocks required and the software automatically generate two distinct sets of random number.

"Sealed Envelope" will generate patient numbers into block of four and divide them into groups. While procreating random numbers and thus equally distribute the patients into two comparable groups. The randomization and sequence generation process will be conducted by a competent third person who has no relationship with this study.

Data analysis will be done by using SPSS software. After collection of data from the patients, all data will be checked and entered carefully. Data will be interpreted by descriptive frequency of the relevant variables The primary analysis will be a stratified log-rank test of the time to recovery with Ivermectin and Doxycycline as compared with standard protocol, with stratification by disease severity.

Descriptive frequency of baseline investigation, follow up table on 2nd, 3rd and 4th day, Final outcome table on 5th day and 10thday will also be presented.

Study Type

Interventional

Enrollment (Anticipated)

188

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ivermectin plus Doxycycline plus standard care
Tab Ivermectin (6mg): 12mg first dose then one more dose of 12mgafter 12 hours 2) Cap. Doxycycline (100mg): 1+0+1 after meal for 10 days. To be taken with half glass of water and sit up for 20 minutes 3) Standard symptomatic and supportive treatment; Tab paracetamol, tab antihistamine, tab montelukast will be mostly used as symptomatic treatment, vitamin C and vitamin D as supplements
Drug: Ivermectin and Doxycycline
  1. Tab Ivermectin (6mg): 12mg first dose then one more dose of 12mgafter 12 hours
  2. Cap. Doxycycline (100mg): 1+0+1 after meal for 10 days. To be taken with half glass of water and sit up for 20 minutes
Placebo Comparator: Placebo plus standard care

1) Standard symptomatic and supportive treatment with placebo; Standard treatment includes tab paracetamol, tab antihistamine, tab montelukast will be mostly used as symptomatic treatment, vitamin C and vitamin D as supplements.

Placebo (1) 2 tab stat then again 2 tab after 12 hours Placebo (2) will be given as 1+0+1 for 10 days
Other: Placebo
Placebo (1) 2 tab stat then again 2 tab after 12 hours Placebo (2) will be given as 1+0+1 for 10 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to outcome measure of fever (<100.40F)and cough
Time Frame: 10 days
Outcome measure of symptoms associated with covid, fever and cough
10 days
Negative RT-PCR test on day 5 of treatment
Time Frame: 10 days
If the result of RT-PCR test is negative, then 24 hours apart another RT-PCR test will be done. Subject to 2 consecutive negative tests patient will be declared as cured
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bangladesh Medical Research Council (BMRC)

Investigators

  • Principal Investigator: Mohammad Tarek Alam, MD, Bangladesh Medical College Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2020

Primary Completion (Anticipated)

November 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

September 3, 2020

First Submitted That Met QC Criteria

September 15, 2020

First Posted (Actual)

September 16, 2020

Study Record Updates

Last Update Posted (Actual)

September 16, 2020

Last Update Submitted That Met QC Criteria

September 15, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 31211062020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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