Covid19 Clinical Trial
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
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
Status | Not yet recruiting |
Enrollment | 188 |
Est. completion date | December 2020 |
Est. primary completion date | November 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Bangladesh Medical Research Council (BMRC) |
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Conforti C, Giuffrida R, Zalaudek I, Di Meo N. Doxycycline, a widely used antibiotic in dermatology with a possible anti-inflammatory action against IL-6 in COVID-19 outbreak. Dermatol Ther. 2020 Apr 20:e13437. doi: 10.1111/dth.13437. [Epub ahead of print] — View Citation
Götz V, Magar L, Dornfeld D, Giese S, Pohlmann A, Höper D, Kong BW, Jans DA, Beer M, Haller O, Schwemmle M. Influenza A viruses escape from MxA restriction at the expense of efficient nuclear vRNP import. Sci Rep. 2016 Mar 18;6:23138. doi: 10.1038/srep23138. Erratum in: Sci Rep. 2016 May 09;6:25428. — View Citation
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* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to outcome measure of fever (<100.40F)and cough | Outcome measure of symptoms associated with covid, fever and cough | 10 days | |
Primary | 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 | 10 days |
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