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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 ...
Clinical trials in India refers to clinical research in India in which researchers test drugs and other treatments on research participants. NDCTR 2019 and section 3.7.1 to 3.7.3 of ICMR guidelines [ 1 ] requires that all researchers conducting a clinical trial must publicly document it in the Clinical Trials Registry - India .
In May 2021, Drugs Controller General of India (DCGI) approved clinical trials in the age group of 2 to 18 years. [48] The trials are conducted at AIIMS Delhi and Patna. [49] As many as 54 children had registered at the AIIMS Patna. [50] In total 525 participants are enrolled in the study as per clinical trial data. [51]
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.
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]
Trials indicate many vaccines developed for the initial strain have lower efficacy for some variants against symptomatic COVID-19. [454] As of February 2021 [update] , the US Food and Drug Administration believed that all FDA authorized vaccines remained effective in protecting against circulating strains of SARS-CoV-2.
The authors came to the conclusion that no further trials of hydroxychloroquine or chloroquine for treatment of COVID-19 should be carried out. [58] On 26 April 2021, in its amended clinical management protocol for COVID-19, the Indian Ministry of Health lists hydroxychloroquine for use in patients during the early course of the disease. [23]