Clinical trial NCT04728880: Remdesivir in Adults With Covid-19: Mansoura University Hospital Experience
Official title: Remdesivir in Adults With Covid-19: Mansoura University Hospital Experience
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pneumonia, Viral
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2021-01-28
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with COVID-19 in Mansoura University Isolation Hospital.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in Pulse rate
timeFrame: 15 days
measure: Change from baseline in respiratory rate
timeFrame: 15 days
measure: Change from baseline in body core temperature
timeFrame: 15 days
measure: Change from baseline in blood pressure
timeFrame: 15 days
measure: Change from baseline in arterial blood gas analyses
timeFrame: 15 days
measure: Change from baseline in Spo2 / FIO2 ratio
timeFrame: 15 days
measure: Change from baseline in White blood cell count
timeFrame: 15 days
measure: Change from baseline in lymphocyte count
timeFrame: 15 days
measure: Change from baseline in lactate dehydrogenase
timeFrame: 15 days
measure: Change from baseline in D-dimer
timeFrame: 15 days
measure: Change from baseline in procalcitonin
timeFrame: 15 days
measure: Change from baseline in Interleukin-6
timeFrame: 15 days
measure: Change from baseline in Serum ferretin
timeFrame: 15 days
measure: Change from baseline in prothrombin time
timeFrame: 15 days
measure: Change from baseline in serum creatinine
timeFrame: 15 days
measure: Change from baseline in liver enzyme ALT
timeFrame: 15 days
measure: Change from baseline in creatinine kinase
timeFrame: 15 days
measure: Change from baseline in cardiac troponin
timeFrame: 15 days
measure: Change from baseline in The Sequential Organ Failure Assessment score (SOFA score)
timeFrame: 15 days
Secondary outcomes:
measure: Duration of hospitalization
timeFrame: 15 days
measure: Supplemental Oxygen Requirement from Baseline
timeFrame: 15 days
measure: Duration without mechanical ventilation
timeFrame: 15 days
measure: Mortality
timeFrame: 15 days
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Hospital
state: Dakahliya
Study officials:
References: