Clinical trial NCT04551755: Safety and Efficacy of Ivermectin and Doxycycline in Treatment of Covid-19
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Covid19
Lead sponsor: Bangladesh Medical Research Council (BMRC)
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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.

Eligibility 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

Primary outcomes:
measure: Time to outcome measure of fever (<100.40F)and cough
timeFrame: 10 days
measure: Negative RT-PCR test on day 5 of treatment
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Bangladesh Medical College Hospital
name: Mohammad Tarek Alam, MD
role: PRINCIPAL_INVESTIGATOR
References:
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