Prevention of Severe Covid-19 in Infected Elderly by Early Administration of Convalescent Plasma With High-titers of Antibody Against SARS-CoV2
Keywords
Abstract
Dates
Last Verified: | 06/30/2020 |
First Submitted: | 06/28/2020 |
Estimated Enrollment Submitted: | 07/18/2020 |
First Posted: | 07/20/2020 |
Last Update Submitted: | 07/18/2020 |
Last Update Posted: | 07/20/2020 |
Actual Study Start Date: | 06/03/2020 |
Estimated Primary Completion Date: | 07/29/2020 |
Estimated Study Completion Date: | 07/29/2020 |
Condition or disease
Intervention/treatment
Biological: Plasma
Other: Placebo
Phase
Arm Groups
Arm | Intervention/treatment |
---|---|
Experimental: Plasma Convalescent plasma with an IgG titer against SARS-CoV2 | Biological: Plasma 250 ml Convalescent plasma with an IgG titer against SARS CoV2 |
Placebo Comparator: Placebo Normal Saline 0.9% | Other: Placebo Normal Saline 0.9% |
Eligibility Criteria
Ages Eligible for Study | 65 Years To 65 Years |
Sexes Eligible for Study | All |
Accepts Healthy Volunteers | Yes |
Criteria | Inclusion Criteria: - Age ≥ 75 or age 65-74 with at least 1 of the following comorbidities: arterial hypertension, diabetes, obesity, chronic obstructive pulmonary disease, heart disease, chronic kidney disease - Last 48 hours: (A)Axillary temperature ≥ 37.5oC or febrile equivalent, combined with (a) dry cough and/or (b) breathing difficulty and/or (c) odinophagia and/or (d) anosmia/dysgeusia and/or (e) any of the following symptoms: fatigue, anorexia, myalgias or rhinorrhea. - Confirmed diagnosis SARS-Cov2 by RT-PCR - Give Informed consent Exclusion Criteria: - Severe respiratory disease - Cardiac insufficiency, - Chronic renal failure, - Primary hypogammaglobulinemias, - Myelodysplastic syndromes, - Chronic linfoproliferative syndromes, - Monoclonal gammapathies, - Known hypersensitibility, - Active cancer, - HIV, HBV or HCV infection, - Chronic administration of immunosuppressants, - Body transplant history, - Chronic liver disease, Chronic lung disease with oxygen requirement. |
Outcome
Primary Outcome Measures
1. Development of severe respiratory disease defined as a respiratory rate (RR)>30 and/or an O2 sat<93% [From 12 hours post infusion to day 15 post infusion]
Secondary Outcome Measures
1. Life threatening respiratory disease [From 12 hours post infusion to day 25 post infusion]
2. Critical systemic illness, defined as respiratory failure [From 12 hours post infusion to day 25 post infusion]
3. Death [From 12 hours post infusion to day 25 post infusion]