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Efficacy and Safety of Sirolimus in COVID-19 Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04461340
Recruitment Status : Recruiting
First Posted : July 8, 2020
Last Update Posted : September 9, 2020
Sponsor:
Information provided by (Responsible Party):
Mohamed Mamdouh Mahmoud Mohamed Elsayed , MD, Alexandria University

Brief Summary:
This research is planned to illustrate the efficacy and safety of sirolimus as an adjuvant agent to the standard treatment protocol against COVID-19 infection

Condition or disease Intervention/treatment Phase
COVID 19 Drug: Sirolimus Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: single-blinded randomized clinical trial in which participants will be randomly assigned to one of the study groups using block randomization with a ratio of 1:1.
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Sirolimus for Treating COVID-19 Infection
Actual Study Start Date : August 15, 2020
Estimated Primary Completion Date : October 30, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Sirolimus

Arm Intervention/treatment
Experimental: Group A
20 patients will receive sirolimus ( oral dose of 6 mg on day 1 followed by 2 mg daily for 9 days) plus national standard of care therapy against COVID 19
Drug: Sirolimus
oral dose of 6 mg on day1 followed by 2 mg daily for 9 days
Other Name: Rapamune

No Intervention: Group B
20 patients will receive only national standard of care therapy against COVID 19



Primary Outcome Measures :
  1. Time to clinical recovery [ Time Frame: 14-28 days ]
    The duration from start of treatment to normalization of pyrexia, respiratory rate ,O2 saturation and relief of cough that is maintained for at least 72 hours.

  2. Viral clearance [ Time Frame: 14 days ]
    Two successive negative COVID-19 PCR analysis tests 48-72 hours apart


Secondary Outcome Measures :
  1. radiological lung extension [ Time Frame: 14 days ]
    Evaluate the lung extension of pneumonia at day 14

  2. drug adverse events [ Time Frame: 28 days ]
    incidence and type of adverse events

  3. 28 day mortality [ Time Frame: 28 day ]
    number of deaths to total number of patients

  4. intensive care unit (ICU) admission rate [ Time Frame: 28 days ]
    deteriorated patients who need admission to intensive care unit

  5. Duration of hospital stay [ Time Frame: 28 days ]
    duration from hospitalization to discharge



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

Inclusion Criteria:

  • Adults (˃18 years) COVID-19 positive patients (confirmed by PCR).
  • Moderate infection ( pneumonia ± leucopenia or lymphopenia ).

Exclusion Criteria:

  • Severe or life threatening COVID infection: Severe disease is defined as: dyspnea, respiratory frequency ≥ 30/min, blood oxygen saturation ≤ 93%, partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300, and/or lung infiltrates > 50% within 24 to 48 hours. Life threatening disease is defined as: respiratory failure, septic shock, and/or multiple organ dysfunction or failure .
  • Pregnant or lactating females.
  • Participation in any investigational clinical study, other than observational, within the past 30 days; or plans to participate in such a study at any time from the day of enrollment until 30 days post-treatment in the current study.
  • Allergy or hypersensitivity to sirolimus.
  • Taking immunosuppressive drugs.
  • Glomerular filtration rate (GFR) < 30 ml/min by CKD-EPI equation.
  • liver cirrhosis .
  • Decompensated heart failure.
  • known active tuberculosis (TB) or history of incompletely treated TB.
  • Uncontrolled systemic bacterial or fungal infections.
  • Drugs that may affect sirolimus level: antifungals, diltiazem, verapamil, nicardipine, phenytoin, phenobarbital, rifampicin, carbamazepine.

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): NCT04461340


Contacts
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Contact: Mohamed Mamdouh Elsayed, MD 00201068055103 dr_mohamedmamdouh87@yahoo.com
Contact: Ayman I Baess, MD 00201006822068 Ayman.baeis@yahoo.com

Locations
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Egypt
Faculty of Medicine, Alexandria university, Egypt Recruiting
Alexandria, Egypt, 21526
Contact: Mohamed Mamdouh Elsayed, MD    00201068055103    dr_mohamedmamdouh87@yahoo.com   
Sponsors and Collaborators
Alexandria University
Investigators
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Principal Investigator: Mohamed Mamdouh Elsayed, MD lecturer
Study Chair: Ayman I Baess, MD Associate professor
Study Chair: Heba M El weshahi, MD professor
Study Chair: Nermine H Zakaria, MD professor
Publications:

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Responsible Party: Mohamed Mamdouh Mahmoud Mohamed Elsayed , MD, lecturer, Alexandria University
ClinicalTrials.gov Identifier: NCT04461340    
Other Study ID Numbers: sirolimus in COVID 19
First Posted: July 8, 2020    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mohamed Mamdouh Mahmoud Mohamed Elsayed , MD, Alexandria University:
sirolimus
COVID 19
Additional relevant MeSH terms:
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Infection
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs