Covid19 Clinical Trial
Official title:
Intravenous Immunoglobulins for the Treatment of Covid-19 Patients: a Clinical Trial
The current project is based on the immunological studies covering the potential of disease induced immunoglobulins as treatment regime. We would be able to generate the concentrated antibodies specific against coronavirus (Covid-19). These antibodies can be used as serum therapy. Aside from a Covid-19 vaccine, antibodies from recovered patients could provide a short-term "passive immunization" to the disease. Those antibodies can be extracted from the blood serum of surviving patients and then injected into infected people. Passive immunization usually lasts for a few weeks or months, after which those borrowed or donated antibodies, get broken down by the host body within about 30 days. While drugs to treat patients with covid-19, and vaccines to prevent infection are being developed, a fast acting, stopgap serum therapy could be useful as a first aid for high-risk patients.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | November 15, 2020 |
Est. primary completion date | October 15, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: - Age > 18 yrs - Both genders - Lab Confirmed COVID-19 infection by PCR or plasma positive of specific antibody against COVID-19 - In hospital treatment = 72 hours - Admitted patients - Mild to moderately severe patients Exclusion Criteria: - Exist of other evidences that can explain pneumonia including but not limited to influenza A virus, influenza B virus, bacterial pneumonia, fungal pneumonia, noninfectious causes, etc. - Patients with respiratory diseases other than Covid-19 infection - Pregnant and breastfeeding women |
Country | Name | City | State |
---|---|---|---|
Pakistan | University of Health Sciences | Lahore | Punjab |
Lead Sponsor | Collaborator |
---|---|
University of Health Sciences Lahore | Amson Vaccine and Pharma (Pvt) Limited, University of Lahore |
Pakistan,
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* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | In hospital days | total number of days the patient remain in hospital | 14 days or discharge | |
Primary | 14 day mortality | mortality if any in the study duration of 14 days | 14 days | |
Secondary | D-dimers | reduction in D-dimers (< 250 ng/mL) | 7 days | |
Secondary | C-reactive protein | reduction in C-Reactive protein (less than 10 mg/L) | 7 days | |
Secondary | Oxygen saturation | improvement in oxygen saturation (pulse oximeter readings within range of 95 to 100%) | 7 days | |
Secondary | TNF alpha | reduction in TNF alpha after IVIG treatment (upto 8.1 pg/mL) | 7 days | |
Secondary | IL-6 | reduction in IL-6 after IVIG treatment | 7 days | |
Secondary | Ferritin | reduction in ferritin levels after IVIG treatment | 7 days | |
Secondary | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | safety and tolerability | 14 days |
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