Clinical trial NCT04816942: Clinical Efficacy of Early Administration of Convalescent Plasma Among COVID-19 Cases in Egypt
Official title: Clinical Efficacy of Early Administration of Convalescent Plasma Among COVID-19 Cases in Egypt
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Convalescent Plasma
Covid19
Immunoglobulins
Plasma
Egypt
Lead sponsor: Ministry of Health and Population, Egypt
Sponsor class: OTHER_GOV
First posted: 2021-03-25
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: One investigational treatment being explored for COVID-19 is the use of convalescent plasma collected from individuals who have recovered from COVID-19 (Refs. 1-4). Convalescent plasma that contains antibodies to severe acute respiratory syndrome coronavirus 2 or SARSCoV-2 (the virus that causes COVID-19) is being studied for administration to patients with COVID-19. Use of convalescent plasma has been studied in outbreaks of other respiratory infections, including the 2003 SARS-CoV-1 epidemic, the 2009-2010 H1N1 influenza virus pandemic, and the 2012 MERS-CoV epidemic (Refs. 5-7).

Although promising, convalescent plasma has not yet been shown to be safe and effective as a treatment for COVID-19. Therefore, it is important to study the safety and efficacy of COVID19 convalescent plasma in clinical trials. This guidance provides recommendations to health care providers and investigators on the administration and study of investigational convalescent plasma collected from individuals who have recovered from COVID-19 (COVID-19 convalescent plasma) during the public health emergency. This guidance also provides recommendations to blood establishments on the collection of COVID-19 convalescent plasma..

Detailed description: laboratory-confirmed patients using qRT-PCR will be enrolled in the study. Eligibility criteria for recipients are ; laboratory-confirmed SARS-CoV-2, Severe or immediately life-threatening. Severe disease defined as one or more of the following; shortness of breath( dyspnoea), respiratory frequency≥ 30/min, blood oxygen saturation ≤93%, a partial pressure of arterial oxygen to fraction of inspired oxygen ratio \<300, and lung infiltrates \>50% within 24-48 hours. While a life-threatening disease is defined as one or more of the following; respiratory failure, need for mechanical ventilation, septic shock and multiple organ dysfunction or failure.

Intervention: All patients included in the study provided will be administered with two plasma units (each unit is 200cc).

Primary measure is the degree of clinical improvement among the COVID-19 patients who receive CPT within seven days as compared with the patients who receive after seven days. Case Fatality will be assessed among the enrolled cases

Eligibility criteria: Inclusion Criteria:

Laboratory confirmed COVID-19. Severe or immediately life-threatening COVID-19,

Exclusion Criteria Not fitting inclusion criteria

Primary outcomes:
measure: COVID-19 Cure rate
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ministry of Health
state: Giza
Study officials:
References: