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

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: Unknown
• Conditions: Pneumonia, Viral
• Intervention / Treatment: Drug: Remdesivir

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: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Supplemental Oxygen Requirement from Baseline	Duration of increased supplemental oxygen requirement from baseline	15 days
Duration of hospitalization	Number of days of hospital admission either in ICU or ward till date of discharge	15 days
Duration without mechanical ventilation	Duration without mechanical ventilation within 15 days of initiation of treatment with Remdesivir	15 days
Mortality	Mortality at 15 days after initiation of treatment with Remdesivir.	15 days

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 26, 2021
• Primary Completion (Anticipated): March 31, 2021
• Study Completion (Anticipated): May 30, 2021

Study Registration Dates

• First Submitted: January 26, 2021
• First Submitted That Met QC Criteria: January 27, 2021
• First Posted (Actual): January 28, 2021

Study Record Updates

• Last Update Posted (Actual): January 28, 2021
• Last Update Submitted That Met QC Criteria: January 27, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia; Lung Diseases; Pneumonia, Viral; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Antimetabolites; Remdesivir
• Other Study ID Numbers: R.20.11.1097

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED