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SARS-CoV-2 convalescent plasmaWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (7)

Name (Synonyms) Correlation
drug1463 Melatonin 2mg Wiki 0.58
drug2500 Therapeutic plasma exchange (TPE) Wiki 0.58
drug1868 Plasma from a volunteer donor Wiki 0.58
drug1710 Otilimab Wiki 0.58
drug2326 Standard of care Wiki 0.26
drug1853 Placebo oral tablet Wiki 0.11
drug1822 Placebo Wiki 0.03

Correlated MeSH Terms (3)

Name (Synonyms) Correlation
D018352 Coronavirus Infections NIH 0.07
D045169 Severe Acute Respiratory Syndrome NIH 0.06
D007239 Infection NIH 0.03

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There are 3 clinical trials

Clinical Trials

1 Comparison of the Efficacy and Safety of Human Coronavirus Immune Plasma (HCIP) vs. Control (SARS-CoV-2 Non-immune) Plasma Among Outpatients With Symptomatic COVID-19.

To assess the efficacy and safety of Human coronavirus immune plasma (HCIP) to reduce the risk of hospitalization or death, the duration of symptoms and duration of nasopharyngeal or oropharyngeal viral shedding.

NCT04373460 SARS-CoV 2 Biological: SARS-CoV-2 convalescent plasma Biological: Plasma from a volunteer donor

Primary Outcomes

Description: Cumulative incidence measured as the proportion of subjects who were hospitalized or who died prior to hospitalization

Measure: Cumulative incidence of hospitalization or death prior to hospitalization

Time: Up to day 28

Description: Cumulative incidence of treatment-related serious adverse events categorized separately as either severe infusion reactions or Acute Respiratory Distress Syndrome (ARDS) during the study period.

Measure: Cumulative incidence of treatment-related serious adverse events

Time: Up to day 28

Description: Cumulative incidence measured as the proportion of subjects experiencing a Grade 3 or higher.

Measure: Cumulative incidence of treatment-related grade 3 or higher adverse events

Time: Up to day 90

Secondary Outcomes

Description: Analysis of serum SARS-CoV-2 antibody titers will also primarily be descriptive, comparing the geometric mean titers at day 0, 14, 28 and 90 between the randomized arms and calculating the shift or change in the titer distribution.

Measure: Change in serum SARS-CoV-2 antibody titers

Time: Days 0, 14, 28 and 90

Description: Compare the rates and duration of SARS-CoV-2 RNA positivity (by RT-PCR) of nasopharyngeal or oropharyngeal fluid between active and control groups at days 0, 14 and 28

Measure: Time to SARS-CoV-2 Polymerase Chain Reaction (PCR) negativity

Time: Day 0, 14 and 28

Other Outcomes

Description: Compare the levels of SARS-CoV-2 RNA between active and control groups at days 0, 14 and 28

Measure: Change in level of SARS-CoV-2 RNA

Time: Day 0, 14 and 28

Description: Comparison of participant self-assessed blood oxygen saturation levels (in percentage oxygen) between treatment arms using pulse oximetry from Day 0 to Day 28.

Measure: Change in oxygen saturation levels

Time: Day 0 to Day 28 (where available)

Description: Secondary infection will be assessed by measuring the number of individuals that live in the same house as the active arm who became sick by the end of follow-up period.

Measure: Rate of participant-reported secondary infection of housemates

Time: Up to day 90

Description: Disease severity measured by time (in days) to admission to the ICU or , invasive mechanical ventilation or time to death.

Measure: Time to ICU admission, invasive mechanical ventilation or death in hospital

Time: Up to day 90

Description: Time (in days) to resolution of COVID-19 symptoms will be based on temperature logs and symptom score sheets.

Measure: Time to resolution of COVID-19 symptoms

Time: Up to day 90

Description: Assess change in hospitalization rate as measured by number of hospitalizations stratified by age groups <65 and >=65

Measure: Impact of convalescent plasma on outcome as assessed by change in hospitalization rate

Time: Day 0 to Day 90

Description: Impact of donor antibody titers (high/low) will be assessed by hospitalization rate as measured by number of hospitalizations.

Measure: Impact of donor antibody titers on hospitalizaton rate of convalescent plasma recipients

Time: Day 0 to Day 90

Description: Impact of donor antibody titers (high/low) will be assessed by antibody levels

Measure: Impact of donor antibody titers on antibody levels of convalescent plasma recipients

Time: Day 0 to Day 90

Description: Impact of donor antibody titers (high/low) will be assessed by viral positivity rates (number of SARS-CoV-2 positive cases per total cases)

Measure: Impact of donor antibody titers on viral positivity rates of convalescent plasma recipients

Time: Day 0 to Day 90

2 Convalescent Plasma for Treatment of COVID-19: An Exploratory Dose Identifying Study

Convalescent plasma has been shown to be safe and effective for treatment of several diseases. Preliminary data indicates that it is safe and effective for treatment of COVID. However, data is limited to small studies and case series on severely ill patients. In a preliminary safety study 10 patients with severe COVID-19, defined as requiring supplementary oxygen, having fever and a duration of illness less than 11 days were treated with 200 ml of CP. CP was given as a slow infusion without obvious adverse events. Eight patients had viremia. One patient rapidly cleared the virus and recovered following CP treatment. CP infusion did not appear to clear viremia in 7/8 patients. Five of these were eventually admitted to ICU. Thus CP did not appear to cause acute toxicity but did not seem to be effective at the dose used. Viremia seemed to be a marker of a high risk of disease progression The proposed study thus aims to treat a high risk population identified by having viremia irrespective of but hopefully before they develop pulmonary injury such that they require supplementary oxygen therapy. Moreover the dose of plasma will be increased incrementally with the aim of clearing viremia as our initial study indicates that continued viremia is driving COVID-19.

NCT04384497 COVID-19 Biological: SARS-CoV-2 convalescent plasma

Primary Outcomes

Description: Progression to non-invasive or invasive ventilation or a sustained requirement of 15L of supplementary oxygen therapy in patients that are not eligible for intensive care treatment.

Measure: Number and proportion of patients with progression to ventilation or sustained requirement of supplementary oxygen therapy

Time: Measured in the first 28 days after inclusion.

Secondary Outcomes

Description: Adverse reactions and serious adverse reactions. The safety of the intervention will be assessed with regard to AEs, baseline medical conditions, and findings from the physical examination and laboratory tests. Possible adverse events will be elicited using a modification and Swedish translation (appendix 6) of Common Terminology Criteria for Adverse Events v5.0 and they will be continuously reported to the sponsor. Adverse events related to convalescent plasma therapy shall be followed to assess reversibility.

Measure: Adverse events

Time: The reporting period for AEs starts at inclusion and ends at the final follow-up visit 2 months after inclusion.

Description: Measured as doses of convalescent plasma administered (1-7 infusions, 200ml).

Measure: Dose of plasma needed to clear viremia

Time: 28 days

Description: SARS-CoV-2 RNA detection by PCR in blood or serum. Blood samples for immunological analyses and serology will be taken daily until discharge, on day 28, and at 6 months.

Measure: Clearance of viremia

Time: 6 months.

Description: Time to resolution of fever and symptoms. Breathing rate, peripheral oxygen saturation (measured with pulse oximetry after 20 minutes of rest), oxygen use, pulse, blood pressure, body temperature and mental state will be monitored 3 times/day while hospitalized.

Measure: Fever and symptoms

Time: Until discharged from the hospital, up to 2 months

Description: Time to normalization of inflammatory parameters. Blood samples for inflammatory parameters will be taken daily until normalized or discharged from the hospital.

Measure: Inflammatory parameters

Time: Until discharged from the hospital, up to 2 months

Description: Characterization of the antibody response to SARS-CoV-2. Blood samples for immunological analyses and serology will be taken daily until discharge, on day 28, and at 6 months.

Measure: Antibody response to SARS-CoV-2

Time: 6 months

3 Plasma From Individuals Who Have Recovered From Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection as Treatment for Acute COVID-19 Disease

There is currently no effective treatment for COVID-19 except best supportive care. The aim is assess the safety, tolerability and efficacy of convalescent plasma for treatment of patients with varying degrees of COVID-19 illness. Convalescent plasma has been shown to be safe and effective for treatment of several diseases. Preliminary data indicates that it is safe and effective for treatment of COVID-19. However, data is limited to small studies and case series on severely ill patients. The proposed study assesses the safety and efficacy earlier in the course of illness, in slightly less severe patients with the possibility of detecting less severe adverse events and the potential for early treatment to hinder the development of severe disease. Plasma is collected from consenting donors who have recovered from SARS-CoV-2.

NCT04390178 COVID-19 Biological: SARS-CoV-2 convalescent plasma
MeSH:Coronavirus Infections

Primary Outcomes

Description: Decrease in progression to requiring non-invasive or invasive ventilation

Measure: Disease progression

Time: 28 days

Secondary Outcomes

Description: Adverse reactions and serious adverse reactions. The safety of the intervention will be assessed with regard to AEs, baseline medical conditions, and findings from the physical examination and laboratory tests. Possible adverse events will be elicited using a modification and Swedish translation (appendix 6) of Common Terminology Criteria for Adverse Events v5.0 and they will be continuously reported to the sponsor. Adverse events related to convalescent plasma therapy shall be followed to assess reversibility.

Measure: Adverse events (AE)

Time: The reporting period for AEs starts at inclusion and ends at the final follow-up visit 2 months after inclusion.

Description: Measured daily until discharged from the hospital.

Measure: Time ro resolution of fever and symptoms

Time: Until discharged from the hospital, up to 2 months

Description: SARS-CoV-2 RNA detection by polymerase chain reaction (PCR) in blood or serum. Blood samples for immunological analyses and serology will be taken daily until discharge, on day 28, and at 6 months.

Measure: Clearance of viraemia

Time: Evaluated daily until discharge, at day 28, and last measurement taken at 6 months of follow-up after inclusion.

Description: Time to normalization of inflammatory parameters. The markers that will be monitored are the following: C-reactive protein (CRP), white blood cell count (WBC), haemoglobin (Hb), Pro-calcitonin, and Creatine Kinase. Blood samples for these markers will be taken daily until normalized or discharged from hospital.

Measure: Inflammatory parameters

Time: Until discharged from the hospital, up to 2 months

Description: Change in the antibody response to SARS-CoV-2 as measured in serum. Blood samples for immunological analyses and serology will be taken daily until discharge, on day 28, and at 6 months.

Measure: Antibody response to SARS-CoV-2

Time: Evaluated daily until discharge, at day 28, and last measurement taken at 6 months of follow-up after inclusion.

No related HPO nodes (Using clinical trials)