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This is a prospective, double blind, randomized, placebo controlled clinical trial. The participants will be randomized into two groups (group A and group B). Patients of group-A are the treatment group. They will be treated with optimal treatment based on the algorithm proposed in National Guidelines on Clinical Management of Coronavirus Disease 2019 (Covid-19) Version 7.0, 28 May 2020, along with Colchicine for 14 days. The patients in group-B will be controlled group. They will be treated with optimal treatment based on the algorithm proposed in National Guideline along with a placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRAETMENT GROUP | Active Comparator | Participants in the colchicine treatment group will be given a starting dose of 1.2 mg of Colchicine (2 tablets of 0.6 mg )single or 12 hourly divided dose. After that, they will take colchicine 0.6mg daily for 13 days. If they develop gastro intestinal side effects e.g abdominal pain, burning, vomiting, diarrhea, omeprazole and antiemetic will be prescribed. |
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| CONTROL /PLACEBO GROUP | Placebo Comparator | COVID-19 Patients in this arm will receive standard COVID-19 treatment according to national guidelines of Bangladesh and will receive placebo. Standard care of enrolled study patients will consist:
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|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colchicine | Drug | Participants in this group will be given a starting dose of 1.2 mg of Colchicine (2 tablets of 0.6 mg )single or 12 hourly divided dose. After that, they will take colchicine 0.6mg daily for 13 days. If they develop gastro intestinal side effects e.g abdominal pain, burning, vomiting, diarrhea, omeprazole and antiemetic will be prescribed. Supportive care and treatment will also be given. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to develop clinical deterioration, defined as the time from randomization to a deterioration of two points (from the status at randomization) on a Seven-category ordinal scale. | Seven-category ordinal scale. The scale is recommended by the WHO R&D Blueprint expert group. The seven-category ordinal scale consisted of the following categories: 1, not hospitalized with resumption of normal activities; 2, not hospitalized, but unable to resume normal activities; 3, hospitalized, not requiring supplemental oxygen; 4, hospitalized, requiring supplemental oxygen; 5, hospitalized, requiring nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both; 6, hospitalized, requiring ECMO, invasive mechanical ventilation, or both; and 7, death | 14 days following randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay | Days from date of enrollment to date of discharge | 14 days following randomization |
| Number of participant requiring increased amount of supplemental oxygen | Proportion of participants who required oxygen supplementation |
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Inclusion criteria:
Males and females of least 18 years of age and can swallow tablets
Competent and willing to provide informed consent
Patient must have received a diagnosis of COVID-19 infection with positive RT-PCR for SARS CoV-2 within the last 3 days
Patients with moderate symptoms (According to National Guidelines on Clinical Management of Coronavirus Disease 2019 (COVID- 19).Version 7.0 .2020, DGHS, MOHFW, Government of the People's Republic of Bangladesh). Following features of moderate covid-19 must be present-
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mujibur Rahman, MBBS,MD,FCPS | Professor and Head, Department of Medicine | Study Chair |
| Motlabur Rahman, MBBS, FCPS,FACP | Associate Professor, Department of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dhaka Medical College Hospital | Dhaka-1000 | Bangladesh |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36383611 | Derived | Rahman M, Datta PK, Islam K, Haque M, Mahmud R, Mallik U, Hasan P, Haque M, Faruq I, Sharif M, Ratul RH, Azad KAK, Miah T, Rahman MM. Efficacy of colchicine in patients with moderate COVID-19: A double-blinded, randomized, placebo-controlled trial. PLoS One. 2022 Nov 16;17(11):e0277790. doi: 10.1371/journal.pone.0277790. eCollection 2022. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D003078 | Colchicine |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | Participants in this group will be given a starting dose of 2 tablets of Placebo, single or 12 hourly divided dose. After that, they will take one placebo tablet daily for 13 days.Placebo tablet will be identical with the Colchicine tablet. If patients develop gastro intestinal side effects e.g abdominal pain, burning, vomiting, diarrhea, omeprazole and antiemetic will be prescribed. Supportive care and treatment will also be given. |
|
| 14 days following randomization |
| Number of participants requiring mechanical ventilation | Proportion of participants who required mechanical ventilation | 14 days following randomization |
| Number of participants who die | Proportion of participants who die from any cause | 14 days following randomization |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |