A Phase 2 interventional study of Ivermectin and Doxycycline and Placebo in Covid19, sponsored by Bangladesh Medical Research Council (BMRC). Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-16.
Sponsored by Bangladesh Medical Research Council (BMRC) · Phase 2, Interventional, and Treatment
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
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 188 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Bangladesh Medical Research Council (BMRC) is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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) 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
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 (1) 2 tab stat then again 2 tab after 12 hours Placebo (2) will be given as 1+0+1 for 10 days
Time to outcome measure of fever (<100.40F)and cough
Outcome measure of symptoms associated with covid, fever and cough
Time frame: 10 days
Negative RT-PCR test on day 5 of treatment
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
Time frame: 10 days
No study locations are listed for this record.
Plan to share: No
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Bangladesh Medical Research Council (BMRC)