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Role of Co-trimoxazole in Severe COVID-19 Patients

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ClinicalTrials.gov Identifier: NCT04470531
Recruitment Status : Recruiting
First Posted : July 14, 2020
Last Update Posted : July 16, 2020
Sponsor:
Collaborators:
Anwar Khan Mordern Medical College and Hospital, Dhaka
Mugda Medical College and Hospital, Dhaka
Information provided by (Responsible Party):
Prof. Dr. Shohael Mahmud Arafat, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Brief Summary:

Coronavirus Disease 19 (COVID-19) is a global pandemic caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Severe disease occurs in 15% of the cases with COVID-19 and may progress to critical disease in only 5% of the cases with a high risk of mortality. Critical disease may present as acute respiratory failure secondary to Acute Respiratory Distress Syndrome (ARDS) and is caused by the body's hyper-immune response to the virus in the form of a cytokine storm syndrome (CSS). There is currently no effective anti-viral treatment against SARS-CoV-2 and the mainstay of treatment is supportive. Co-trimoxazole (combination of trimethoprim and sulphamethoxazole in a 1:5) ratio is a Sulphur containing anti-folate bactericidal antibiotic indicated for the treatment of respiratory tract infections. It has been around for over 60 years and is inexpensive and readily available with a good safety profile. It has a rapid onset of action with excellent bioavailability and lung penetration. In addition to having antimicrobial properties co-trimoxazole have immunomodulatory and anti-inflammatory properties and may be a potential treatment option for cytokine storm syndrome mediated severe COVID-19.

This open-label randomized controlled trial will be conducted in the department of medicine at Bangabandhu Sheikh Mujib Medical University (BSMMU), Anwar Khan Modern Medical college and Mughda Medical College Hospital (DMCH), Dhaka for a duration of 6 months following approval of this protocol. It will recruit at least 94 consecutive adults (18 years or older) patients with clinically suspected COVID-19 and severe illness as per WHO criteria. After taking informed written consent patients will be randomly assigned in a 1:1 ratio to either oral co-trimoxazole in addition to standard therapy or standard therapy alone. Baseline characteristics, changes in the physiological and biochemical parameters like (SpO2/FiO2 ratio, respiratory rate, body temperature and C - reactive protein), length of hospital stay, side effects of drugs, requirement for ventilatory support (non-invasive and invasive ventilation) and in-patient mortality between the two groups will be compared.

Conclusion If the results from this clinical trial demonstrate the beneficial effects of co-trimoxazole in severe COVID-19 patients it could be used widely, thereby reducing the need for respiratory support and potentially saving thousands of lives in developing nations with limited resources where healthcare may be easily overwhelmed.


Condition or disease Intervention/treatment Phase
Covid19 Severe COVID-19 Patients Drug: oral co-trimoxazole Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Arm A :control group will receive standard treatment, Arm B: experimental group will receive standard care and oral co-triamoxazole
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Role of Co-trimoxazole in Severe COVID-19 Patients
Actual Study Start Date : July 12, 2020
Estimated Primary Completion Date : October 12, 2020
Estimated Study Completion Date : January 30, 2021

Arm Intervention/treatment
No Intervention: Control

Arm A :No Intervention/control: Standard treatment

  1. Antibiotics for secondary bacterial infection as per institutional guidelines
  2. Supplemental oxygen (to keep saturations between 90% to 96%)
  3. Intravenous hydration (to maintain euvolumia)
  4. Thrombo-prophylaxis as per local guidelines
  5. Paracetamol (oral or I/V 1gram QDS as required or regular)
  6. To consider steroids if indicated (i.e. acute exacerbation of COPD or acute severe asthma)
Experimental: intervention /experimental

Arm B: Experimental Arm received oral co-trimoxazole + standard therapy

The following treatments are recommended as standard therapy:

  1. Antibiotics for secondary bacterial infection as per institutional guidelines
  2. Supplemental oxygen (to keep saturations between 90% to 96%)
  3. Intravenous hydration (to maintain euvolumia)
  4. Thrombo-prophylaxis as per local guidelines
  5. Paracetamol (oral or I/V 1gram QDS as required or regular)
  6. To consider steroids if indicated (i.e. acute exacerbation of COPD or acute severe asthma)
Drug: oral co-trimoxazole
oral co-trimoxazole + standard therapy
Other Name: co-trimoxazole




Primary Outcome Measures :
  1. Length of stay in hospital (in days) [ Time Frame: 14 days ]
    Duration of hospital stay in days

  2. In-patient mortality [ Time Frame: 14 days ]
    % of patients died after enrollment


Secondary Outcome Measures :
  1. SpO2/FiO2 ratio [ Time Frame: Day 1,2,3,4 and 5 ]
    ratio of Saturation of oxygen in % and Fraction of inspired oxygen

  2. respiratory rate [ Time Frame: Day 1,2,3,4 and 5 ]
    Respiratory rate per minute

  3. C-reactive Protein [ Time Frame: Day 1,2,3,4 and 5 ]
    CRP level in mg/litre

  4. Fever [ Time Frame: Day 1,2,3,4 and 5 ]
    Temperature in degree Fahrenheit

  5. Ventilator support [ Time Frame: 14 days ]
    Requirement of ventilator support in hours

  6. Proportion of drug adverse reaction [ Time Frame: 24 hours ]
    % of patients developed early reaction like fever, rash, abdominal pain, urticaria, vomiting, wheezing, chest tightness



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosed COVID-19 patients ( RT-PCR positive for COVID-19)
  2. Age > 18 years
  3. Hypoxic respiratory failure (saturation <90% on air at rest or increasing oxygen requirement)
  4. Chest examination findings of bilateral crackles on auscultation or chest x-ray showing bilateral infiltrates
  5. C-Reactive Protein > 50mg/L

Exclusion Criteria:

  1. Multi-organ failure
  2. Severe ARDS (requiring ventilator support on presentation in the form of invasive or non-invasive ventilation)
  3. Septic Shock
  4. Severe liver disease
  5. Acute Kidney Injury (where GFR< 15 and plasma-sulfamethoxazoleconcentration cannot be monitored)
  6. Drug allergy/intolerance to co-trimoxazole / Sulphar sensitivity
  7. Pregnancy
  8. Already receiving Tocilizumab or convalescent therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04470531


Contacts
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Contact: Shohael Arafat, FCPS 01732330313 arafat2001@gmail.com
Contact: Rehan Quadery arafat2001@gmail.com

Locations
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Bangladesh
Bangabandhu Sheikh Mujib Medical University Recruiting
Dhaka, Bangladesh, 1200
Contact: Shohael Arafat, FCPS    01732330313    arafat2001@gmail.com   
Contact: Rehan Quadery         
Sponsors and Collaborators
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Anwar Khan Mordern Medical College and Hospital, Dhaka
Mugda Medical College and Hospital, Dhaka
Investigators
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Study Chair: Shohael Arafat ICMJE
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Responsible Party: Prof. Dr. Shohael Mahmud Arafat, Chairman and professor of internal medicine, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
ClinicalTrials.gov Identifier: NCT04470531    
Other Study ID Numbers: BSMMU/2020/6969
First Posted: July 14, 2020    Key Record Dates
Last Update Posted: July 16, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be shared with the journal authority and make public as part of the publication
Supporting Materials: Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: six months
Access Criteria: Available on public domain like figshare, researchgate and others

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Trimethoprim, Sulfamethoxazole Drug Combination
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents