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

Study Overview
=================
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.

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

Conditions
-----------------
Pneumonia, Viral

Intervention / Treatment
-----------------
* Drug: Remdesivir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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). Exclusion Criteria: Presences of chronic renal failure > 4 stage, GFR < 30ml/min. ALT/AST > 5 times than normal values. Pregnant women.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: 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.|

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 |
| --- | --- | --- |
| Duration of hospitalization | Number of days of hospital admission either in ICU or ward till date of discharge | 15 days | 
| Supplemental Oxygen Requirement from Baseline | Duration of increased supplemental oxygen requirement from baseline | 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 |