Covid 19 Clinical Trials

The novel coronavirus disease (COVID-19), which began in Wuhan, China, in December 2019, has been declared to be a pandemic by the World Health Organization (WHO), Caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), COVID-19 has resulted in 1,781,127 cases and 108,994 deaths globally (till 12th April, 2020), affecting 199 countries and 2 international conveyances. US FDA has recently approved Convalescent Plasma from patients recovered from COVID 19 for the treatment of severe or life threatening COVID-19 infections. In a small case series, five critically ill COVID-19 patients with ARDS were treated with convalescent plasma containing neutralizing antibodies. Infusion of plasma was followed by improvement in clinical status in all five patients, with no deaths and the study reported that three patients were discharged, whilst two continued to be stable on mechanical ventilation. We designed this phase II, open label, randomized clinical trial with the primary objective to assess the safety and efficacy of the therapy in the second stage.

NCT04374487 COVID 19 Drug: Convalescent Plasma Other: Standard Care Therapy

Primary Outcomes

Description: Baseline data about the demography, clinical presentations, ongoing medical therapy, and clinical history of participants in both arms will be collected and compared. Response to convalescent plasma will be coded as a binary outcome - based on whether the composite primary end point is met or not. All the statistical tests will be done at 5% level of significance and SPSS21 will be used for calculations.

Measure: The primary outcome is a composite measure of the avoidance of - 1. Progression to severe ARDS (P/F ratio 100) and 2. All-cause Mortality at 28 days

Time: depends on the total treatment time of the subjects within one year period of the trial.

Secondary Outcomes

Description: Data from both arm will be collected and compared time to time

Measure: Time to symptom resolution-Fever,Shortness of Breath,Fatigue

Time: one year

Description: total time of stay at hospital for the treatment and cure will be calculated and compared of both the arms

Measure: Hospital length of stay

Time: one year

Description: sepsis-related organ failure assessment (SOFA) score will be calculated for both the arms and compared for the analysis.

Measure: Change in SOFA pre and post transfusion

Time: one year

Description: Most COVID patients admitted to intensive care require some form of respiratory support. Whether or not the plasma therapy decreases the duration of respiratory support and its comparison with the standard care therapy will be calculated.

Measure: Duration of respiratory support required a. Duration of Invasive Mechanical Ventilation b. Duration of Non-Invasive

Time: one year

Description: Comparison between group response rates will be analyzed by radiological imaging and reported.

Measure: Radiological improvement

Time: one year

Description: Adverse events associated with infusion of convalescent plasma will also be descriptively summarized and compared with the adverse events experienced by participants receiving standard of care.

Measure: Adverse events (AE) associated with transfusion

Time: one year

Description: Ct values from day 0, 1, 3 & 7 will be calculated by RT-PCR and compared to check the response of therapy on the viral load. All the statistical tests will be done at 5% level of significance and SPSS21 will be used for calculations.

Measure: To measure the change in RNA levels (Ct values) of SARS-CoV-2 from RT-PCR [Time Frame: Days 0, 1, 3, and 7 after transfusion]

Time: one year

Description: Bio-markers can play a role in understanding how existing drugs can be used to treat Covid-19. Hence, pre and post Plasma transfusion the level of bio-markers will be checked and compared.

Measure: Levels of bio-markers pre and post transfusion

Time: one year

Description: For critically ill subjects in both the arms the need of vasopressor will be compared. All these comparisons are for qualitative data and will be assessed for statistical significance by Fisher exact test in view of the small sample size.

Measure: Need of Vasopressor use

Time: one year

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Clinical Trials

1 A Phase II, Open Label, Randomized Controlled Trial to Assess the Safety and Efficacy of Convalescent Plasma to Limit COVID-19 Associated Complications

NCT04374487 COVID 19 Drug: Convalescent Plasma Other: Standard Care Therapy

Primary Outcomes

Secondary Outcomes

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