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Antiviral Drugs on the Treatment of SARS-CoV-2 (FavRem)

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: NCT04727775
Recruitment Status : Recruiting
First Posted : January 27, 2021
Last Update Posted : June 7, 2021
Sponsor:
Information provided by (Responsible Party):
Aidos Konkayev, Astana Medical University

Brief Summary:
Retrospective Non-Randomized Analytical Cohort Study of Completed SARS-CoV2 COVID19 Cases

Condition or disease Intervention/treatment
Complication of Medical Care Pneumonia, Viral Drug: Favipiravir Drug: Remdesivir

Detailed Description:
Analyzing the case histories of patients with SARS-CoV2 COVID19 infection and the impact on the outcomes of prescribing antiviral drugs

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Retrospective Study of the Effect of Antiviral Drugs on the Treatment of SARS-CoV-2 COVID19
Actual Study Start Date : December 1, 2020
Estimated Primary Completion Date : November 25, 2021
Estimated Study Completion Date : December 25, 2021

Group/Cohort Intervention/treatment
Complications
Evaluathion
Drug: Favipiravir
Antiviral drugs

Drug: Remdesivir
Antiviral drugs

Oxygen status
Evaluathion
Drug: Favipiravir
Antiviral drugs

Drug: Remdesivir
Antiviral drugs

Oxugen support
Evaluathion
Drug: Favipiravir
Antiviral drugs

Drug: Remdesivir
Antiviral drugs




Primary Outcome Measures :
  1. Outcome without comlications [ Time Frame: 14 days ]
    The recovery time will be evaluated with and without antiviral drugs retrospectively in homogeneous groups of patients with SARS-CoV2


Secondary Outcome Measures :
  1. Heart rate [ Time Frame: 14 days ]
    Measure

  2. SpO2 [ Time Frame: 14 days ]
    Measure

  3. Blood pressure [ Time Frame: 14 days ]
    Measure

  4. Respiratory rate [ Time Frame: 14 days ]
    Measure



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with previous covid 19 pneumonia
Criteria

Inclusion Criteria:

main group

  • Patients with COVID19 with medium and easy condition disease
  • take favipiravir/remdisivir control group
  • Patients with COVID19 with medium and easy condition disease
  • not take favipiravir/remdisivir

Exclusion Criteria:

  • patients younger 18
  • severe conditionis

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): NCT04727775


Locations
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Kazakhstan
Aidos Konkaev Recruiting
Nur-Sultan, Kazakhstan, 010000
Contact: Aidos Konkaev, PhD    87475339215    konkaev@mail.ru   
Semey Medical University Recruiting
Semey, Kazakhstan, 071407
Contact: Tolkin Bolegenov, MD    +7775 756 3038    smu@nao-mus.kz   
Sponsors and Collaborators
Astana Medical University
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Responsible Party: Aidos Konkayev, doctor, Astana Medical University
ClinicalTrials.gov Identifier: NCT04727775    
Other Study ID Numbers: AMU
First Posted: January 27, 2021    Key Record Dates
Last Update Posted: June 7, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Retrospective study

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumonia, Viral
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases