Probiotic and Colchicine in COVID-19

NCT05911022 | Completed DMC

• 1 other identifier: COVID-19
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID-19

Keywords

Probiotics, Colchicine, COVID-19, Ain Shams University.

Outcome Measures

Primary Outcomes (1)

• symptoms improvement

  Discharge from isolation after 10 days after symptom onset, plus at least 3 additional days without symptoms (including without fever and without respiratory symptoms) According to WHO recommendations published on 27 May 2020.

  two weeks

Secondary Outcomes (2)

• Development of new symptoms.

  two weeks

• Need for oxygen supplementation.

  two weeks

Study Arms (3)

Group A (Colchicine group)

ACTIVE COMPARATOR

consisted of COVID-19 participants with mild to moderate disease who received the recommended course of care in accordance with the protocol established by the Egyptian Supreme Council of University Hospitals, as well as Colchicine tablets (0.5 mg) three times per day for three days and subsequently twice per day for four days

Drug: Colchicine 0.5 MG

Group B (Probiotic group)

ACTIVE COMPARATOR

consisted of COVID-19 participants with mild and moderate COVID-19 severity got probiotics in the form of oral sachets once daily for two weeks in addition to protocol prescribed by the Egyptian Supreme Council of University Hospitals.

Dietary Supplement: Probiotic Formula

Group C (Control group)

PLACEBO COMPARATOR

consisted of COVID-19 participants with mild and moderate severity who received the recommended course of care in accordance with the protocol established by 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, and necessary protocol of management based on case assessment and severity).

Other: Standard protocol

Interventions

Colchicine 0.5 MG DRUG

three times per day for three days and subsequently twice per day for four days

Group A (Colchicine group)

Probiotic Formula DIETARY_SUPPLEMENT

oral sachets once daily for two weeks

Group B (Probiotic group)

Standard protocol OTHER

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

Group C (Control group)

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participants aged (18-60) years with confirmed criteria of COVID-19 infection. Mild cases: Participants have mild symptoms such as anosmia, loss of taste, fever or respiratory tract symptoms, gastrointestinal symptoms, etc. and free chest imaging. Moderate Cases: Participants have symptoms such as fever, respiratory tract symptoms, gastrointestinal symptoms, etc. and pneumonia manifestations can be seen in chest imaging

You may not qualify if:

• Age below 18 years or above 60 years.
• Pregnancy, lactation.
• Any co-morbidities e.g. (DM, hypertension, Asthma)
• Participants receiving immunosuppressive or chemotherapy drugs.
• Active malignancy
• Severe confirmed cases, fulfilling any of the following criteria:
• Respiratory rate more than 30/min.
• Blood oxygen saturation of less than 93%.
• Lung infiltrates \>50% of the lung fields or rapid progression within 24-48 hours.
• Participants need respiratory support e.g. high flow oxygen, non-invasive or invasive mechanical ventilation.
• Critical cases defined as: occurrence of respiratory failure requiring mechanical ventilation; Presence of shock; other organ failure that requires monitoring and treatment in the ICU

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, 190519, Egypt

Location

MeSH Terms

Conditions

COVID-19

Interventions

Colchicine; AIEOP acute lymphoblastic leukemia protocol

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The researcher will use sealed envelopes containing code for intervention or control.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: Three-arm randomized controlled interventional study

Study Record Dates

• First Submitted: June 17, 2023
• First Posted: June 20, 2023
• Study Start: July 1, 2021
• Primary Completion: August 30, 2022
• Study Completion: August 30, 2022
• Last Updated: June 23, 2023

Record last verified: 2023-06

Locations

EG (1)