Remdesivir in Adults With Covid-19: Mansoura University Hospital Experience

NCT ID: NCT04728880

Last Updated: 2021-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-26

Study Completion Date

2021-05-30

Brief Summary

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COVID-19 is a respiratory disease caused by a new coronavirus (SARS-CoV-2) and causes significant morbidity and mortality. This study is a retrospective trial to assess the efficacy of Remdesivir in adult patients diagnosed with COVID-19 in Mansoura University Isolation Hospital. In this study the investigators will analyze the data collected during treatment.

Detailed Description

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COVID-19 is a novel respiratory disease caused by coronavirus (SARS-CoV-2) and results in significant morbidity and mortality. To date there is no approved medication for the treatment of patients with COVID-19. Remdesivir is a broad-spectrum antiviral nucleotide analogue that inhibits RNA-dependent RNA polymerase activity among a diverse group of RNA viruses. Non-clinical and clinical data suggest that Remdesivir may be useful for the treatment of COVID-19. WHO has identified Remdesivir as a candidate drug of interest to be studied in clinical trials. This retrospective study is designed to analyze the data collected during the routine care of patients who have benefited from this therapy.

Conditions

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Pneumonia, Viral

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Remdesivir

This study is a retrospective trial to assess the efficacy of Remdesivir in adult patients diagnosed with COVID-19 in Mansoura University Isolation Hospital. In this study we will analyze the data collected during treatment.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Adult ≥ 18 years old.
2. SARS-CoV-2 infection confirmed.
3. Patients having classical radiological lesions of COVID-19 on X-ray chest or HRCT chest.
4. Hospitalized patients who received at least one administration of Remdesivir therapy (Dose: 200mg day one then 100mg daily for up to 10 days).

Exclusion Criteria

1. Presences of chronic renal failure \> 4 stage, GFR \< 30ml/min.
2. ALT/AST \> 5 times than normal values.
3. Pregnant women.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Mostafa Bakeer

Lecturer of chest medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mansoura University Hospital

Al Mansurah, Dakahliya, Egypt

Site Status RECRUITING

Countries

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Egypt

Facility Contacts

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El Sharawy Kamal, Professor

Role: primary

002 050 2202876

Other Identifiers

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R.20.11.1097

Identifier Type: -

Identifier Source: org_study_id

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