NCT04728880

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

January 26, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 28, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2021

Completed
Last Updated

January 28, 2021

Status Verified

January 1, 2021

Enrollment Period

2 months

First QC Date

January 26, 2021

Last Update Submit

January 27, 2021

Conditions

Pneumonia, Viral

Outcome Measures

Primary Outcomes (19)

  • Change from baseline in Pulse rate

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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)

    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 Outcomes (4)

  • Duration of hospitalization

    15 days

  • Supplemental Oxygen Requirement from Baseline

    15 days

  • Duration without mechanical ventilation

    15 days

  • Mortality

    15 days

Interventions

RemdesivirDRUG

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.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Presences of chronic renal failure \> 4 stage, GFR \< 30ml/min.
  • ALT/AST \> 5 times than normal values.
  • Pregnant women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University Hospital

Al Mansurah, Dakahliya, 35511, Egypt

RECRUITING

MeSH Terms

Conditions

Pneumonia, Viral

Interventions

remdesivir

Condition Hierarchy (Ancestors)

PneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of chest medicine

Study Record Dates

First Submitted

January 26, 2021

First Posted

January 28, 2021

Study Start

January 26, 2021

Primary Completion

March 31, 2021

Study Completion

May 30, 2021

Last Updated

January 28, 2021

Record last verified: 2021-01

Locations

EG(1)