Changes to trial information |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Official scientific title |
14/07/2020 |
edit |
A randomized control trial comparing convalescent plasma therapy to standard treatment in patients with severe COVID 19 pneumonia at a tertiary hospital |
A randomized control trial comparing convalescent plasma therapy to standard treatment in patients with severe COVID-19 pneumonia at a tertiary hospital |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Eligibility |
Age group |
14/07/2020 |
edit to include max age of 80 years |
Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s) |
Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s), 80 and over: 80+ Year |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Acronym |
15/07/2020 |
None |
|
None |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Actual trial start date |
15/07/2020 |
None |
|
01 Aug 2020 |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Completion date |
15/07/2020 |
None |
|
31 Dec 2021 |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Publication URL |
15/07/2020 |
None |
|
Not yet sent for publication |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Study Design |
Allocation concealment |
15/07/2020 |
Advise from ethics committee |
Central randomisation by phone/fax |
Numbered containers |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Intervention |
Intervention List |
15/07/2020 |
Advise from ethics committee |
Experimental Group, Convalescent plasma group, 350mls given once, over 4 hours, The acquired convalescent plasma will be transfused to the eligible new admitted Covid 19 positive ICU patient with respiratory failure after ABO and Rhesus match. Patients will receive 350ml of convalescent plasma over 4 hours. Standard safety precautions observed during a blood transfusion will be followed. In the event of an acute transfusion reaction, the blood bank and principal investigator will be notified immediately. Clinical data as well as the standard laboratory studies will be collected at baseline, 1 hour after dose, day 1, 3, 7, 14, 28 of hospital stay after enrollment., 103, |
Experimental Group, Convalescent plasma group, 350mls given once, over 4 hours, The acquired convalescent plasma will be transfused to the eligible new admitted Covid 19 positive ICU patient with respiratory failure after ABO and Rhesus match. Patients will receive 350ml of convalescent plasma over 4 hours. Standard safety precautions observed during a blood transfusion will be followed. In the event of an acute transfusion reaction, the blood bank, chairman of ethics committee and principal investigator will be notified immediately. Clinical data as well as the standard laboratory studies will be collected at baseline, 1 hour after dose, day 1, 3, 7, 14, 28 of hospital stay after enrollment., 103, |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Intervention |
Intervention List |
15/07/2020 |
None |
|
Control Group, Standard treatment, None, None, Patient will receive standard COVID 19 treatment as per the national guidelines, 103, Active-Treatment of Control Group |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Eligibility |
Exclusion criteria |
15/07/2020 |
Spacing |
• Viral pneumonia with other viruses besides COVID-19.
• Patients are not suitable for Convalescent Plasma Therapy e.g. history of allergic reaction to blood or blood products
• Participation in other studies.
• Other circumstances in which the investigator determined that the patient is not suitable for the clinical trial e.g. Jehovah witnesses
• Refusal to give informed consent by Donor and/or 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)
• Females who are pregnant or breast feeding.
|
• Viral pneumonia with other viruses besides COVID-19.
• Patients are not suitable for Convalescent Plasma Therapy e.g. history of allergic reaction to blood or blood products
• Participation in other studies.
• Other circumstances in which the investigator determined that the patient is not suitable for the clinical trial e.g. Jehovah witnesses
• Refusal to give informed consent by Donor and/or 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)
• Females who are pregnant or breast feeding.
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Funding Source |
FundingSources List |
15/07/2020 |
Added funding source |
|
Kenyatta University Teaching Referral and Research Hospital, 7674, Nairobi, 00100, Kenya, Hospital, |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Collaborators |
Collaborators List |
15/07/2020 |
Added collaborator |
|
Dr Marion Kiguoya Njau, 7674, Nairobi, 00100, Kenya |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Collaborators |
Collaborators List |
15/07/2020 |
Added collaborator |
|
Dr Kimondo Mutambuki, 7674, Nairobi, 00100, Kenya |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Collaborators |
Collaborators List |
15/07/2020 |
Added collaborators |
|
Dr Peter Karuiki Ngugi, 7674, Nairobi, 00100, Kenya |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Collaborators |
Collaborators List |
15/07/2020 |
Added collaborator |
|
Dr Sultana Sherman, 7674, Nairobi, 00100, Kenya |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Collaborators |
Collaborators List |
15/07/2020 |
Added collaborator |
|
Dr mary Mwangi, 7674, Nairobi, 00100, Kenya |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Contact People |
Contacs List |
15/07/2020 |
Added postal code |
Public Enquiries, Marion, Kiguoya Njau, Dr., marionwangui2002@gmail.com, , +254722877863, 7674, Nairobi, , Kenya, Deputy Director Research |
Public Enquiries, Marion, Kiguoya Njau, Dr., marionwangui2002@gmail.com, , +254722877863, 7674, Nairobi, 00100, Kenya, Deputy Director Research |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Reporting |
Plan to share IPD |
15/07/2020 |
Undecided |
No |
Undecided |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Final no of participants |
16/07/2020 |
Missing figure |
|
206 |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Study Design |
Allocation concealment |
16/07/2020 |
Addition from ethics committee |
Numbered containers |
Sealed opaque envelopes |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Intervention |
Intervention List |
16/07/2020 |
Additional information |
|
Experimental Group, Convalescent plasma group, 350mls of convalescent plasma transfused as a single dose, over 4 hours, The acquired convalescent plasma will be transfused to the eligible new admitted Covid 19 positive ICU patient with respiratory failure after ABO and Rhesus match. Patients will receive 350ml of convalescent plasma over 4 hours. Standard safety precautions observed during a blood transfusion will be followed. In the event of an acute transfusion reaction, the blood bank, chairman of ethics committee and principal investigator will be notified immediately. Clinical data as well as the standard laboratory studies will be collected at baseline, 1 hour after dose, day 1, 3, 7, 14, 28 of hospital stay after enrollment., 103, |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Eligibility |
Inclusion criteria |
16/07/2020 |
Rephrased the inclusion criteria |
1. Relatives/Patients of Covid 19 positive patients who have understood and signed the informed consent;
2. Age ≥18 years, gender unlimited;
3. Patients diagnosed with acute severe Covid 19 pneumonia: Laboratory confirmed infection with Covid 19. At least one of the following conditions should be met:
• Respiratory distress defined as oxygen saturation ≤ 90% in resting state and PaO2/FiO2 ≤300mmHg;
|
1. Covid 19 Patients or relatives of Covid 19 positive patients who have understood and signed the informed consent;
2. Age ≥18 years, gender unlimited;
3. Patients diagnosed with acute severe Covid 19 pneumonia: Laboratory confirmed infection with Covid 19. At least one of the following conditions should be met:
• Respiratory distress defined as oxygen saturation ≤ 90% in resting state and PaO2/FiO2 ≤300mmHg;
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Ethics |
Ethics List |
16/07/2020 |
Uploaded Ethics approval letter |
TRUE, Kenyatta University Ethics Review Committee, 43844, Nairobi, 00100, Kenya, , 10 Jul 2020, +2548710901, chairman.kuerc@ku.ac.ke, 11047_11525_4737.pdf |
TRUE, Kenyatta University Ethics Review Committee, 43844, Nairobi, 00100, Kenya, , 10 Jul 2020, +2548710901, chairman.kuerc@ku.ac.ke, 11047_11525_4737.pdf |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Reporting |
Plan to share IPD |
16/07/2020 |
Requirement by WHO |
Undecided |
Yes |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Reporting |
IPD description |
16/07/2020 |
Requirement by WHO |
|
Use of convalescent plasma therapy in COVID-19 is an experimental therapy. To add to the growing evidence which hopefully will shape use of convalescent plasma therapy in this pandemic, we intend to share our protocol and results that hopefully will form part of a meta-analysis on this subject. |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Reporting |
IPD-Sharing time frame |
16/07/2020 |
Additional information |
|
August 2020 to December 2020 |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Reporting |
Key access criteria |
16/07/2020 |
Additional information |
|
Access to this data will be controlled and the principal investigator will decide ( in consultation with co-investigators) who to grant access to the data |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Reporting |
IPD URL |
16/07/2020 |
None |
|
None |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Reporting |
Study protocol document |
16/07/2020 |
Additional information |
|
Study Protocol, Statistical Analysis Plan, Informed Consent Form, Clinical Study Report, Analytic Code |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Public title |
19/08/2020 |
Suggestion from PPB |
A clinical trial comparing use of convalescent plasma therapy to standard therapy in patients with severe COVID-19 infection |
A clinical trial comparing use of convalescent plasma therapy plus standard treatment to standard treatment alone in patients with severe COVID-19 infection |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Official scientific title |
19/08/2020 |
Suggestion from PPB |
A randomized control trial comparing convalescent plasma therapy to standard treatment in patients with severe COVID-19 pneumonia at a tertiary hospital |
A randomized control trial comparing convalescent plasma therapy plus standard treatment versus standard treatment alone in patients with severe COVID-19 pneumonia at a tertiary hospital |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Trial description |
19/08/2020 |
PPB |
COVID 19 pandemic is as a result of SARs-COV 2 virus that was first reported in Wuhan, China in December 2019. As of 13 May 2020, there were over 4 million reported cases with almost 300000 fatalities. With no effective antiviral therapy and a vaccine a long way to go, use of convalescent plasma therapy has shown promising results in small pilot studies as well as against other known viruses such as MERS, SARS and H1N1 influenza. The primary objective of this trial is to look at the efficacy of convalescent plasma therapy compared to standard treatment against COVID 19 using the WHO 6 category ordinal scale of clinical status. |
COVID 19 pandemic is as a result of SARs-COV 2 virus that was first reported in Wuhan, China in December 2019. As of 13 May 2020, there were over 4 million reported cases with almost 300000 fatalities. With no effective antiviral therapy and a vaccine a long way to go, use of convalescent plasma therapy has shown promising results in small pilot studies as well as against other known viruses such as MERS, SARS and H1N1 influenza. The primary objectives of this trial is to look at the safety and efficacy of convalescent plasma therapy plus standard treatment compared to standard treatment alone in patients with severe COVID 19 using the WHO 6 category ordinal scale of clinical status. |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Trial phase |
19/08/2020 |
PPB |
Phase-2 |
Phase-3 |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Eligibility |
Inclusion criteria |
19/08/2020 |
Suggestion from PPB |
1. Covid 19 Patients or relatives of Covid 19 positive patients who have understood and signed the informed consent;
2. Age ≥18 years, gender unlimited;
3. Patients diagnosed with acute severe Covid 19 pneumonia: Laboratory confirmed infection with Covid 19. At least one of the following conditions should be met:
• Respiratory distress defined as oxygen saturation ≤ 90% in resting state and PaO2/FiO2 ≤300mmHg;
|
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.
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Eligibility |
Exclusion criteria |
19/08/2020 |
Suggestion from PPB |
• Viral pneumonia with other viruses besides COVID-19.
• Patients are not suitable for Convalescent Plasma Therapy e.g. history of allergic reaction to blood or blood products
• Participation in other studies.
• Other circumstances in which the investigator determined that the patient is not suitable for the clinical trial e.g. Jehovah witnesses
• Refusal to give informed consent by Donor and/or 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)
• Females who are pregnant or breast feeding.
|
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
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Outcome |
OutCome List |
19/08/2020 |
Suggestion from PPB |
Primary Outcome, To determine Time to Clinical Improvement (TTCI) [Time Frame: up to 28 days].
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) (7).
Six-category ordinal scale:
6. Death;
5. ICU, requiring IMV;
4. ICU/hospitalization, requiring NIV/ HFNC therapy;
3. Hospitalization, requiring supplemental oxygen (but not NIV/ HFNC);
2. Hospitalization, not requiring supplemental oxygen;
1. Hospital discharge.
Abbreviation: IMV, invasive mechanical ventilation; NIV, non-invasive mechanical ventilation; HFNC, High-flow nasal cannula
, Clinical data as well as the standard laboratory studies will be collected at baseline, 1 hour after dose, day 1, 3, 7, 14, 28 of hospital stay after enrollment. |
Primary Outcome, a) To evaluate safety of convalescent plasma therapy in patients with severe Covid-19.
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].
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).
Six-category ordinal scale:
6. Death;
5. ICU, requiring IMV;
4. ICU/hospitalization, requiring NIV/ HFNC therapy;
3. Hospitalization, requiring supplemental oxygen (but not NIV/ HFNC);
2. Hospitalization, not requiring supplemental oxygen;
1. Hospital discharge.
Abbreviation: IMV, invasive mechanical ventilation; NIV, non-invasive mechanical ventilation; HFNC, High-flow nasal cannula.
, Clinical data as well as the standard laboratory studies will be collected at baseline, 1 hour after dose, 6hrs, day 1, 3, 7, 14, 28 of hospital stay after enrollment. |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Outcome |
OutCome List |
19/08/2020 |
Suggestion from PPB |
Secondary Outcome, • Clinical status assessed by the ordinal scale on days 7, 14, 21, and 28[ Time Frame: up to 28 days] based on SOFA score
• The differences in oxygen intake methods [Time Frame: up to 28 days]
1. No need for supplemental oxygenation
2. Nasal catheter oxygen inhalation
3. Mask oxygen inhalation
4. Noninvasive ventilator oxygen supply
5. Invasive ventilator oxygen supply.
• Duration (days) of supplemental oxygenation [Time Frame: up to 28 days]
• Duration (days) of mechanical ventilation [Time Frame: up to 28 days]
• The mean PaO2/FiO2 [Time Frame: up to 28 days]
• Time to Covid 19 negativity in respiratory tract specimens [every 3 days]
[Time Frame: up to 28 days]
• Length of ICU (days) [Time Frame: up to 28 days]
• Length of hospital stay (days) [ Time Frame: up to 28 days]
• All-cause mortality [Time Frame: up to 28 days]
, Days 7, 14, 21, and 28 based on SOFA score |
Secondary Outcome, • 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.
b) To compare the proportion of patients requiring oxygen supplementation between the intervention and control groups up to 28 days.
c) To compare the proportion of patients on mechanical ventilation between the intervention and control groups up to 28 days.
d) To determine the mean PaO2/FiO2 between the intervention and control groups up to 28 days.
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
f) To determine the length of ICU stay(days) between the intervention and control groups up to 28 days.
g) To determine length of hospital stay (days) between the intervention and control groups up to 28 days.
h) To determine all-cause mortality between the intervention and control groups up to 28 days.
, Days 7, 14, 21, and 28 based on SOFA score |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Collaborators |
Collaborators List |
19/08/2020 |
PPB |
|
Prof Olive Mugenda, 7674, Nairobi, 00100, Kenya |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Collaborators |
Collaborators List |
19/08/2020 |
PPB |
|
Dr Ifrah Hersi, 7674, Nairobi, 00100, Kenya |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Collaborators |
Collaborators List |
19/08/2020 |
PPB |
|
Dr Diane Otieno, 7674, Nairobi, 00100, Kenya |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Collaborators |
Collaborators List |
19/08/2020 |
PPB |
|
Dr Maureen Nganga, 7674, Nairobi, 00100, Kenya |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Collaborators |
Collaborators List |
19/08/2020 |
PPB |
|
Dr Idris, Chikophe, Nairobi, 00100, Kenya |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Collaborators |
Collaborators List |
19/08/2020 |
PPB |
|
Mercy Kahare, 7674, Nairobi, 00100, Kenya |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Collaborators |
Collaborators List |
19/08/2020 |
PPB |
|
Mr Wilfred Gatua, 7674, Nairobi, 00100, Kenya |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Collaborators |
Collaborators List |
19/08/2020 |
PPB |
|
Dr John Kaumba Nzioka, 7674, Nairobi, 00100, Kenya |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Reporting |
IPD-Sharing time frame |
19/08/2020 |
PPB |
August 2020 to December 2020 |
August 2020 to December 2021 |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Intervention |
Intervention List |
19/08/2020 |
Suggestion from PPB |
Experimental Group, Convalescent plasma group, 350mls of convalescent plasma transfused as a single dose, over 4 hours, The acquired convalescent plasma will be transfused to the eligible new admitted Covid 19 positive ICU patient with respiratory failure after ABO and Rhesus match. Patients will receive 350ml of convalescent plasma over 4 hours. Standard safety precautions observed during a blood transfusion will be followed. In the event of an acute transfusion reaction, the blood bank, chairman of ethics committee and principal investigator will be notified immediately. Clinical data as well as the standard laboratory studies will be collected at baseline, 1 hour after dose, day 1, 3, 7, 14, 28 of hospital stay after enrollment., 103, |
Experimental Group, Convalescent plasma group, 350mls of convalescent plasma transfused as a single dose in addition to standard treatment for severe Covid-19, over 4 hours, The acquired ABO and rhesus compatible convalescent plasma will be transfused to the eligible new admitted Covid-19 positive ICU patient with respiratory failure. Patients will receive 350ml of convalescent plasma over 4 hours. Standard safety precautions observed during a blood transfusion will be followed. This includes accurate patient identification, monitoring patient vital signs (temperature, blood pressure, heart rate, respiratory rate), skin, urine color among others(38)(39)( see attached convalescent plasma transfusion chart). In the event of an acute transfusion reaction, standard protocol of stopping transfusion immediately and administering 10mg of chlorpheniramine and 200mg of hydrocortisone intravenously will be followed. The blood bank and principal investigator will be notified immediately. Clinical data as well as the standard laboratory and imaging studies will be collected at baseline, 1 hour, 6 hours after dose, day 1, 3, 7, 14, 28 of hospital stay after enrollment. Counselling of recipients of CP will also be done before transfusion., 103, |