A clinical trial comparing use of convalescent plasma therapy plus standard treatment to standard treatment alone in patients with severe COVID-19 infectio
- Conditions
- COVID 19
- Registration Number
- PACTR202007653923168
- Lead Sponsor
- Kenyatta University Teaching Referral and Research Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 206
Inclusion criteria for donors of CP
(a) Confirmation of previous infection with SARS-CoV2 by a record of RT-PCR test result. At least 2 negative RT-PCR tests after recovery
(b) An interval of at least 14 days after initial illness which is assumed to be the day when the patient had a positive RT-PCR test for SARS-COV2.
(c) Must meet standard criteria for whole blood donation according to Kenyan blood bank requirements and standards (age (>18yrs), weight (>50kg), collection frequency (atleast 3 months since last donation), vital signs within normal ranges, good health) in line with WHO Blood Regulators Network (BRN): Donor selection in case of pandemic situations’.
(d) Non-reactivity of blood samples for transfusion transmitted infections including HIV, HBV, HCV, syphilis (for whole blood) and malaria
(e) To avoid the risk of transfusion-related acute lung injury (TRALI), preference will be given to use of plasma from male donors or from female donors who have never been pregnant including abortions. This measure lowers the possibility of presence in the plasma of the antibodies to HLA or granulocyte antigens that cause TRALI. TRALI occurs within 6 h after transfusion of implicated plasma and can be severe.
Inclusion Criteria for recipients of CP:
1.Confirmed Covid-19 patients with severe disease defined as oxygen saturation = 93 in resting state and PaO2/FiO2 =300mmHg who have understood and signed the written informed consent form. If patients are eligible but are too sick to give consent, their legally authorized close relatives will consent for them.
2.Age =18 years, gender unlimited.
2 Exclusion criteria for donors of CP
a)Patients aged less than 18 years of age (18 years is the legal consent age in Kenya)
b)Symptomatic patients with COVID-19
c)Patients with fever of unknown origin
d)Patients who don’t meet Kenyan standards of blood donation e.g anemic patients, underweight (less than 50kg), chronic diseases such as HIV, hepatitis B and C, cancers, uncontrolled hypertension etc.
e)Females who have given birth or had an abortion due to high risk of TRALI
f)Patients who decline or are unable to give informed consent to donate CP.
Exclusion Criteria for recipients of CP:
•History of allergic reaction to blood or blood products
•Participation in other clinical trials.
•Religious reasons such as Jehovah witnesses’ practitioners who decline blood/blood products.
•Refusal to give informed consent by the patient or next of kin
•Known IgA deficiency
•Medical conditions in which receipt of 350mL volume may be detrimental to the patient (e.g., decompensated congestive heart failure, renal failure)
•Females who are pregnant or breast feeding
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method a)To evaluate safety of convalescent plasma therapy in patients with severe Covid-19.<br>b)To evaluate efficacy of convalescent plasma therapy with standard treatment versus standard treatment alone with respect to time to clinical improvement (TTCI) [Time Frame: up to 28 days].<br>TTCI is defined as the time (in days) from initiation of study treatment (active or standard care) until a decline of two categories from admission status on a six-category ordinal scale of Clinical status which ranges from 1 (discharged) to 6 (death)(35).<br>Six-category ordinal scale:<br>6. Death;<br>5. ICU, requiring IMV;<br>4. ICU/hospitalization, requiring NIV/ HFNC therapy;<br>3. Hospitalization, requiring supplemental oxygen (but not NIV/ HFNC);<br>2. Hospitalization, not requiring supplemental oxygen;<br>1. Hospital discharge.<br>Abbreviation: IMV, invasive mechanical ventilation; NIV, non-invasive mechanical ventilation; HFNC, High-flow nasal cannula.<br>
- Secondary Outcome Measures
Name Time Method •a)To compare duration of severe illness, based on SOFA score, between patients enrolled in the intervention and control groups assessed by the ordinal scale on days 7, 14, 21, and 28.<br>b)To compare the proportion of patients requiring oxygen supplementation between the intervention and control groups up to 28 days.<br>c)To compare the proportion of patients on mechanical ventilation between the intervention and control groups up to 28 days.<br>d)To determine the mean PaO2/FiO2 between the intervention and control groups up to 28 days.<br>e)To determine time to negative SARS-COV2 RT-PCR test in respiratory tract specimens between the intervention and control groups up to 28 days<br>f)To determine the length of ICU stay(days) between the intervention and control groups up to 28 days.<br>g)To determine length of hospital stay (days) between the intervention and control groups up to 28 days.<br>h)To determine all-cause mortality between the intervention and control groups up to 28 days.<br><br>