T1/ Remdesivir Treatment Options for Symptomatic COVID Hospitalized Infections
Drug Details: 200mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Drug Information: Remdesivir is a single diastereomer mono-phosphoramidate pro-drug designed for the intracellular delivery of a modified adenine nucleoside analog GS-441524. In addition to the active ingredient, the lyophilized formulation of Remdesivir contains the following inactive ingredients: water for injection, sulfo-butylether beta-cyclodextrin sodium (SBECD), and hydrochloric acid and/or sodium hydroxide.
There were a total of 1062 participants total of which 521 were given the placebo. And 541 participants were given the actual drug being tested Remdesivir. The overall clinical trial consisted of a series of participants that received either the placebo or the main drug (Remdesivir) over a period of 29 days. The definitions for the trial are stated throughout, including placebo, scales, adverse events, and biomarkers evaluated. From the onset the recovery time period is defined as the first day on which the subject (participant) fits into one of the following three categories in a predefined ordinal scale.
1. Hospitalized, not requiring supplemental oxygen O2,
3. Not hospitalized, no limitations on activities.
Secondary Outcome Results
Participant biomarker levels were determined by analyzing obtained blood samples to evaluate the following: AST/ serum creatinine/ serum glucose /hemoglobin/ platelets/ prothrombin time (PT)/ total bilirubin/ white blood cell count (WBC)/ neutrophils/ lymphocytes/ monocytes/ basophils/eosinophils.
Collected on the following time points Day 1,3,5,8, and 11 while participants were inpatient, and at day 15 and 29 with the day 1 assessment serving as baseline. Participants who havw been discharged had blood collected, if infection control measures allowed for in-person visits after discharge.
The safety population includes all treated participants with available data at baseline and the post baseline assessment point, was analyzed as treated.
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows:
1. Not hospitalized, no limitations on activities
2. Not hospitalized, limitation on activities and/or requiring home oxygen
3. Hospitalized, not requiring supplemental oxygen
no longer requires ongoing medical care
4. Hospitalized, not requiring supplemental oxygen
requiring ongoing medical care Covid-19 related or otherwise
5. Hospitalized, requiring supplemental oxygen
6. Hospitalized, on non-invasive ventilation
7. Hospitalized, on invasive mechanical ventilation or
extracorporeal membrane oxygenation (ECMO)
8. Fatality
Percentage of participants reporting grade 3 and 4 clinical and/or laboratory adverse events (AEs).
Grade 3 AEs are defined as events that interrupt usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Severe events are usually incapacitating. Grade 4 AEs are defined as events that are potentially life threatening.
End Results
All-cause mortality statistics
Placebo: 14.78%
Remdesivir: 10.91%
Serious Adverse events
Placebo: 31.59%
Remdesivir: 24.62%
Other (not including serious) adverse events
Placebo: 57.17%
Remdesivir: 51.88%
While the results do not imply a substantial difference in the infected patient, the drug does contribute an increase of the presence of required immune system response elements. Validating its usage without the implications of possible side effects or pre-existing conditions. Results are primarily targeted towards those who have a severely compromised immune system and/or pre-existing conditions, which upon viral infection of Covid-19 result in a severe inflammatory response.