Covid19 Clinical Trial
Official title:
Impact of Different Treatment Modalities on Immunity Against COVID-19
Verified date | July 2022 |
Source | Beni-Suef University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The first version of this preprint article is registered on the 4th of May 2020 under the digital object identifier of:10.31219/osf.io/u56fc. COVID-19 infections virus spread worldwide and impact many countries with sever economical sequences. The effective antiviral medication or vaccination for the virus is unavailable until the present date and it takes months or years to discover the effective treatment or test the efficacy of the discovered treatment. Based on these facts, the human immune system against the virus may have an effective role to regulate the infection and reduce the mortality rate among the infected patients. This proposed research article aims to explore the available medication/ natural supplementation to boost the immunity system of the patients against COVID-19 infections and reduce the mortality rate among infected patients. Methods: a proposed clinical trial will be carried out to investigate the effect of the different treatment modalities on the human immune system against COVID-19 infection.
Status | Completed |
Enrollment | 150 |
Est. completion date | December 4, 2021 |
Est. primary completion date | November 4, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 25 Years to 40 Years |
Eligibility | Inclusion Criteria: - Symptomatic with respiratory or systemic symptoms - Positive nasopharyngeal swab for COVID-19 - CT imaging showing viral pneumonia - Temperature 38°C - Respiratory rate < 25 /min - Oxygen saturation (pulse oximetry) >95% Exclusion Criteria: - Pregnant or breast feeding - Hepatic failure Child-Pugh C - Negative swab test of (SARS)-(CoV-2) - Expected life is less than 24 hours - End-stage lung disease |
Country | Name | City | State |
---|---|---|---|
Saudi Arabia | Maternity and Children hospital | Mecca | Makkah |
Lead Sponsor | Collaborator |
---|---|
Beni-Suef University | Maternity and Children Hospital, Makkah, University of Arizona |
Saudi Arabia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical improvement | Time to Clinical recovery | 30 Days | |
Primary | Recovery rate from positive to negative swaps | Percentage of patients returned to negative swaps of COVID-19 | 14 Days | |
Primary | Fever to normal temperature in days | Number of days for fever remission T=37.5°C | 15 Days | |
Primary | Remission of lung inflammation in CT or X-ray | Number of days to report lungs recovery in chest X ray or CT | 30 Days | |
Primary | Length of hospitalization | Number of days for hospitalization | 10 Days | |
Primary | (PCR levels) polymerase chain reaction assay levels | Change of (PCR levels) > 50% in comparison with PCR levels at the admission | 10 Days | |
Primary | Respiratory indexes | P O2/Fi O2 which reflects patients' oxygen saturation | 10 Days | |
Primary | C-reactive protein mg/L | C-reactive protein milligrams per deciliter correlated with inflammation | 25 Days | |
Primary | Serum Ferritin ng/ml | Serum Ferritin Nanograms per milliliter correlated with iron overload and illness severity | 25 Days | |
Primary | Lactic acid dehydrogenase U/L | Lactic acid dehydrogenase unit per litter correlated with illness severity | 25 Days | |
Primary | leukocytes count µl | leukocytes in microliter correlated with mortality | 30 Days | |
Primary | Lipid profile [LDL, HDL, Total cholesterol ] | Mg/dl correlated with lipid peroxidation that linked to oxidative stress | 14 Days | |
Primary | total plasma antioxidant capacity | Evaluate the antioxidant response against the free radicals produced in COVID-19 infection measured by ELISA | 14 Days |
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