Probiotic and Colchicine in COVID-19

COVID-19 Clinical Trial

Official title: The Effects of Probiotic Lactobacillus Acidophilus and Colchicine on the Control of Symptoms, Duration, and Disease Progression of Mild and Moderate Cases of COVID-19: A Randomized Controlled Clinical Trial.

Status Completed

Clinical Trial Summary

Probiotics and or Colchicine may be considered as an option of treatment since they have anti-viral effect anti-inflammatory and immunomodulatory effect. A total of 150 participants were were randomly assigned (1:1:1) to receive either the standard treatment protocol and colchicine or the standard treatment protocol and probiotics or the standard treatment protocol alone for two weeks. Participants followed up twice weekly by telephone.

Clinical Trial Description

Rational:

At the end of 2019, a novel coronavirus was identified as the causative of a cluster of pneumonia cases in Wuhan, China. resulting in an epidemic throughout China, followed by a global pandemic. In February 2020, the World Health Organization announced the disease COVID-19, which stands for coronavirus disease 2019.

Gut microbiota configuration was associated with COVID-19 disease severity, and altered gut microbiota persisted even after clearance of the virus, suggesting that the virus might inflict prolonged harm to human microbiome homoeostasis.

Probiotics as an intestinal microbe regulator, not only improve the ability of the GI microbiota to modulate immune activity, but also strengthen the body's immune system, inhibit allergic reactions and has a significant role especially in the anti-viral immunomodulation.

Colchicine is an anti-inflammatory medication commonly used for the treatment systemic auto inflammatory diseases such as familial Mediterranean fever and Behçet's disease. Its mechanism of action is through inhibition of neutrophil chemotaxis and activity in response to vascular injury .

Therefore, in patients with COVID-19, probiotics and or Colchicine, may be a therapeutic choice. However, there is still a lack of evidence-based studies to support this, so it is necessary to conduct further studies and provide evidence to clinicians.

Objectives:

To assess effectiveness of probiotic supplement (Lactobacillus Acidophilus) and Colchicine on symptoms, duration and progression of mild and moderate cases of COVID-19 infection.

Participants:

Participants with mild and moderate COVID-19 severity, aged 18 to 64 were included in the trial.

Sample size:

A total of 150 participants who satisfied the inclusion criteria had their data gathered between the beginning of July 2021 and the end of August 2022.

Randomization:

To distribute intervention or control codes, the investigator used sealed envelopes. Fifty participants was included in each group( 25 mild and 25 moderate cases).

Intervention:

Participants were randomly assigned (1:1:1) to receive either the standard treatment protocol and colchicine or the standard treatment protocol and probiotics or the standard treatment protocol alone or for two weeks.

Data collection:

each participants had the following procedures:

1. Sociodemographic information was gathered for the clinical history, including age, gender, marital status, place of residence, smoking history, etc.

2. Medical information included weight, current medications, symptoms (onset, course, and duration), and the presence of co-morbidities.

3. The temperature, heart rate, blood pressure, respiratory rate, and oxygen saturation are all measured during a thorough general examination.

participants who met the CDC's criteria for suspicion had radiographic and laboratory confirmation using the tests PCR-COVID-19, Complete Blood Count, CRP, Ferritin and D-Dimer, as well as High-resolution CT chest.

Follow up:

Participants followed up twice weekly by telephone for evaluating their symptoms, development of new symptoms, compliance on treatment, temperature measurement and psychological support.

Data Analysis:

Analysis of data of the participants is divided into three groups, the first patients received Colchicine, the second patients received probiotics and the third control group.

Descriptive statistics including quantitative data presented as mean and SD and Qualitative data presented as number and percentage.

Analytical statistics including bivariate analyses using the chi-square test for categorical variables. For comparison of Lab investigation before and during the treatment Mc Nemar test used for qualitative binary variables and Marginal Homogeneity test used for nominal variables. ;

Related Conditions & MeSH terms

• COVID-19

• NCT number: NCT05911022
• Study type: Interventional
• Source: Ain Shams University
• Status: Completed
• Phase: N/A
• Start date: July 1, 2021
• Completion date: August 30, 2022