Probiotic and Colchicine in COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Colchicine 0.5 MG; Probiotic Formula; Standard protocol
Intervention type(s): Drug; Dietary Supplement; Other
Intervention description(s): three times per day for three days and subsequently twice per day for four days; oral sachets once daily for two weeks; the Egyptian Supreme Council of University Hospitals (Vitamin C 500 mg twice daily, Vitamin D3 2000-4000 IU/day, Zinc 75 mg once daily for two weeks
Intervention MeSH terms: Colchicine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Three-arm randomized controlled interventional study
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Probiotics, Colchicine, COVID-19, Ain Shams University.