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

January 27, 2021 updated by: Mostafa Bakeer, Mansoura University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Dakahliya
      • Mansoura, Dakahliya, Egypt, 35511
        • Recruiting
        • Mansoura University Hospital
        • Contact:
          • El Sharawy Kamal, Professor
          • Phone Number: 002 050 2202876
          • Email: muh@mans.edu.eg
        • Principal Investigator:
          • Mostafa Bakeer, Lecturer
        • Principal Investigator:
          • Asem Hewidy, A.Professor
        • Principal Investigator:
          • Ahmed Abo Mossalam, A.Professor
        • Principal Investigator:
          • Tamer El Hadidy, A.Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with COVID-19 in Mansoura University Isolation Hospital.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline in Pulse rate
Time Frame: 15 days
Change from baseline in the pulse rate during clinical course of patients on Day 15 under treatment with Remdesivir.
15 days
Change from baseline in respiratory rate
Time Frame: 15 days
Change from baseline in the respiratory rate during clinical course of patients on Day 15 under treatment with Remdesivir.
15 days
Change from baseline in body core temperature
Time Frame: 15 days
Change from baseline in the body core temperature during clinical course of patients on Day 15 under treatment with Remdesivir.
15 days
Change from baseline in blood pressure
Time Frame: 15 days
Change from baseline in the blood pressure during clinical course of patients on Day 15 under treatment with Remdesivir.
15 days
Change from baseline in arterial blood gas analyses
Time Frame: 15 days
Change from baseline in the arterial blood gas analyses during clinical course of patients on Day 15 under treatment with Remdesivir.
15 days
Change from baseline in Spo2 / FIO2 ratio
Time Frame: 15 days
Change from baseline in the Spo2 / FIO2 ratio during clinical course of patients on Day 15 under treatment with Remdesivir.
15 days
Change from baseline in White blood cell count
Time Frame: 15 days
Change from baseline in the White blood cell count during clinical course of patients on Day 15 under treatment with Remdesivir.
15 days
Change from baseline in lymphocyte count
Time Frame: 15 days
Change from baseline in the lymphocyte count during clinical course of patients on Day 15 under treatment with Remdesivir.
15 days
Change from baseline in lactate dehydrogenase
Time Frame: 15 days
Change from baseline in the lactate dehydrogenase during clinical course of patients on Day 15 under treatment with Remdesivir.
15 days
Change from baseline in D-dimer
Time Frame: 15 days
Change from baseline in the D-dimer during clinical course of patients on Day 15 under treatment with Remdesivir.
15 days
Change from baseline in procalcitonin
Time Frame: 15 days
Change from baseline in the procalcitonin during clinical course of patients on Day 15 under treatment with Remdesivir.
15 days
Change from baseline in Interleukin-6
Time Frame: 15 days
Change from baseline in the Interleukin-6 during clinical course of patients on Day 15 under treatment with Remdesivir.
15 days
Change from baseline in Serum ferretin
Time Frame: 15 days
Change from baseline in the Serum ferretin during clinical course of patients on Day 15 under treatment with Remdesivir.
15 days
Change from baseline in prothrombin time
Time Frame: 15 days
Change from baseline in the prothrombin time during clinical course of patients on Day 15 under treatment with Remdesivir.
15 days
Change from baseline in serum creatinine
Time Frame: 15 days
Change from baseline in the serum creatinine during clinical course of patients on Day 15 under treatment with Remdesivir.
15 days
Change from baseline in liver enzyme ALT
Time Frame: 15 days
Change from baseline in the liver enzyme ALT during clinical course of patients on Day 15 under treatment with Remdesivir.
15 days
Change from baseline in creatinine kinase
Time Frame: 15 days
Change from baseline in the creatinine kinase during clinical course of patients on Day 15 under treatment with Remdesivir.
15 days
Change from baseline in cardiac troponin
Time Frame: 15 days
Change from baseline in the cardiac troponin during clinical course of patients on Day 15 under treatment with Remdesivir.
15 days
Change from baseline in The Sequential Organ Failure Assessment score (SOFA score)
Time Frame: 15 days
The Sequential Organ Failure Assessment (SOFA) is a morbidity severity score and mortality estimation tool. It allows for calculation of both the number and the severity of organ dysfunction in six organ systems (respiratory, coagulatory, liver, cardiovascular, renal, and neurologic). The following values are used to calculate the score: (PaO2 / FiO2 and artificial ventilation; platelets; bilirubin; average blood pressure and use of vasoactive drugs; creatinine).The total score ranges from 0-24. Zero indicates low risk while 24 indicates higher risk of mortality.
15 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Supplemental Oxygen Requirement from Baseline
Time Frame: 15 days
Duration of increased supplemental oxygen requirement from baseline
15 days
Duration of hospitalization
Time Frame: 15 days
Number of days of hospital admission either in ICU or ward till date of discharge
15 days
Duration without mechanical ventilation
Time Frame: 15 days
Duration without mechanical ventilation within 15 days of initiation of treatment with Remdesivir
15 days
Mortality
Time Frame: 15 days
Mortality at 15 days after initiation of treatment with Remdesivir.
15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 26, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 26, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 28, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R.20.11.1097

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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