Colchicine in Moderate Symptomatic COVID-19 Patients

Covid19 Clinical Trial

— COLCOVIDBD  

Official title:

Colchicine in Moderate Symptomatic COVID-19 Patients: Double Blind, Randomized, Placebo Controlled Trial to Observe the Efficacy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04527562
• Other study ID #: U1111-1255-3541
• Status: Completed
• Phase: N/A
• Start date: July 14, 2020
• Est. completion date: December 10, 2020

Study information

• Verified date: January 2021
• Source: Dhaka Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 299
• Est. completion date: December 10, 2020
• Est. primary completion date: November 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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-

1. Fever or history of fever

2. Cough and /or Shortness of breath

3. Oxygen saturation 94% or more

4. Pneumonia -pulmonary consolidations on chest imaging (chest x ray or CT scan of chest) involving less than 50%of lungs

5. CRB 65 score 0

Exclusion criteria:

• Pregnancy and breast-feeding

• Known hypersensitivity to colchicine

• Known chronic illness e.g hepatic failure, chronic kidney disease (eGFR<30ml/min), decompensated heart failure, long QT syndrome (QTc >450 msec.)

• Patient with inflammatory bowel disease (Crohn's disease or ulcerative colitis), chronic diarrhea or malabsorption

• Patient currently taking colchicine for other indications (mainly chronic indications represented by Familial Mediterranean Fever or gout)

• Patient undergoing chemotherapy for cancer

• Patient is considered by the investigator, for any reason, to be an unsuitable candidate for the study.

Related Conditions & MeSH terms

• Covid19

Intervention

Drug:
• Colchicine
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.
• Placebo
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.

Locations

Country	Name	City	State
Bangladesh	Dhaka Medical College Hospital	Dhaka-1000

Sponsors (1)

Lead Sponsor	Collaborator
Dhaka Medical College

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Length of hospital stay	Days from date of enrollment to date of discharge	14 days following randomization
Secondary	Number of participant requiring increased amount of supplemental oxygen	Proportion of participants who required oxygen supplementation	14 days following randomization
Secondary	Number of participants requiring mechanical ventilation	Proportion of participants who required mechanical ventilation	14 days following randomization
Secondary	Number of participants who die	Proportion of participants who die from any cause	14 days following randomization