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The CTRI requests all the information which the World Health Organization recommends for clinical trial registries. [8] Additionally, the CTRI collects information specific to the circumstances of India, including the address of the principal investigator, the name of the ethics committee overseeing the trial and confirmation of their government registration; proof of permission from the Drugs ...
ZyCoV-D is a DNA plasmid-based COVID-19 vaccine developed by Indian pharmaceutical company Cadila Healthcare, with support from the Biotechnology Industry Research Assistance Council. It is approved for emergency use in India.
Enrolling people with COVID-19 infection is simplified by gathering informed consent, and capturing data on an online clinical trial platform (Castor EDC). [ 6 ] [ 2 ] After the trial staff determine the drugs available at the hospital, the platform randomizes the hospitalized subject to one of the trial drugs or to the hospital standard of ...
The Indian Council of Medical Research (ICMR), the apex body in India for the formulation, coordination and promotion of biomedical research, is one of the oldest and largest medical research bodies in the world. The ICMR is funded by the Government of India through the Department of Health Research, Ministry of Health and Family Welfare.
In June 2021, a group of researchers at the National Institute of Virology (NIV) India, collected sera from recovered patients and people who had received the Covaxin. They found the vaccine to be effective in neutralising the Delta ( B.1.617.2 ) and Beta ( B.1.351 ) variants.
The first cases of COVID-19 in India were reported on 30 January 2020 in three towns of Kerala, among three Indian medical students who had returned from Wuhan, the epicenter of the pandemic. [10] [11] [12] Lockdowns were announced in Kerala on 23 March, and in the rest of the country on 25 March. Infection rates started to drop in September. [13]
Bebtelovimab is a neutralizing human immunoglobulin G1 (IgG1) monoclonal antibody, isolated from a patient who has recovered from the Coronavirus disease 2019 (COVID-19), directed against the spike (S) protein of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), that can potentially be used for immunization against COVID-19.
A phase I clinical trial was carried out to evaluate the safety and immunogenicity of the vaccine candidate in about 360 participants. [4] The phase II concluded in April 2021. [12] [13] [14] In April 2021, the Drugs Controller General of India permitted the vaccine candidate to start phase III clinical trials. A total of 1,268 healthy ...