SARS-CoV Infection Clinical Trial
Official title:
Convalescent Plasma for Passive Immunization in COVID-19 ICU Patients: An Interventional Study
Verified date | December 2020 |
Source | Lahore General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Passive immunization involves the administration of antibodies against a given agent to a susceptible individual for the purpose of preventing or treating an infectious disease due to that agent. A general principle of passive antibody therapy is that it is more effective when used for prophylaxis than for treatment of disease. When used for therapy, antibody is most effective when administered shortly after the onset of symptoms
Status | Active, not recruiting |
Enrollment | 20 |
Est. completion date | December 30, 2020 |
Est. primary completion date | December 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 15 Years to 80 Years |
Eligibility | Inclusion criteria: - Severe or critically ill COVID-19 patients tested positive in respiratory tract test. - The COVID-19 patients who are not severe or critically ill, but in a state of immunity suppression; - or have low CT values in the virus nucleic acid testing but with a rapid disease progression in the lungs. - Severe or immediately life-threatening COVID-19, for example, - Severe disease is defined as one or more of the following: - shortness of breath (dyspnea), - respiratory frequency = 30/min, - blood oxygen saturation = 93%, - partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300, - lung infiltrates > 50% within 24 to 48 hours - Within 3 to 21 days from onset of symptoms Exclusion criteria: • Life-threatening disease is defined as one or more of the following: respiratory failure, septic shock, multiple organ dysfunction or failure Critically ill COVID-19 patients will not considered suitable for being transfusion as inflammatory pathway is already set in, so antibodies will not make that much of difference. |
Country | Name | City | State |
---|---|---|---|
Pakistan | Muhammad Irfan Malik | Lahore | Punjab |
Lead Sponsor | Collaborator |
---|---|
Lahore General Hospital |
Pakistan,
Balabolkin MI. [Various problems of thyroidology]. Ter Arkh. 1988;60(9):136-41. Russian. — View Citation
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Hung IF, To KK, Lee CK, Lee KL, Chan K, Yan WW, Liu R, Watt CL, Chan WM, Lai KY, Koo CK, Buckley T, Chow FL, Wong KK, Chan HS, Ching CK, Tang BS, Lau CC, Li IW, Liu SH, Chan KH, Lin CK, Yuen KY. Convalescent plasma treatment reduced mortality in patients with severe pandemic influenza A (H1N1) 2009 virus infection. Clin Infect Dis. 2011 Feb 15;52(4):447-56. doi: 10.1093/cid/ciq106. Epub 2011 Jan 19. — View Citation
Luke TC, Casadevall A, Watowich SJ, Hoffman SL, Beigel JH, Burgess TH. Hark back: passive immunotherapy for influenza and other serious infections. Crit Care Med. 2010 Apr;38(4 Suppl):e66-73. doi: 10.1097/CCM.0b013e3181d44c1e. Review. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | clinical outcome after plasma therapy | Clinical Improvement of COVID-19 patients by giving them passive immunization | 10 days | |
Secondary | Clinical response to treatment | Overall survival of COVID-19 patients after plasma administration. | 10 days |
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