Investigational COVID-19 Convalescent Plasma - Emergency Investigational New Drug (IND)
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Investigational COVID-19 Convalescent Plasma - Emergency Investigational New Drug ,IND
Investigational COVID-19 Convalescent Plasma - Emergency Investigational New Drug , IND
One investigational treatment being explored for COVID-19 involves the use of convalescent plasma collected from recovered COVID-19 patients. It is possible that convalescent plasma that contains antibodies to SARS-CoV-2 the virus that causes COVID-19 might be effective against the infection. Use of convalescent plasma has been studied in outbreaks of other respiratory infections, including the 2009-2010 H1N1 influenza virus pandemic, 2003 SARS-CoV-1 epidemic, and the 2012 MERS-CoV epidemic. Although promising, convalescent plasma has not been shown to be effective in every disease studied. It is therefore important to determine through clinical trials, before routinely administering convalescent plasma to patients with COVID-19, that it is safe and effective to do so. Investigators wishing to study the use of convalescent plasma are encouraged to submit requests to FDA for investigational use under the traditional IND regulatory pathway .
Although participation in clinical trials is one way for patients to obtain access to convalescent plasma, these may not be readily available to all patients in potential need. Therefore, given the public health emergency that the expanding COVID-19 outbreak presents, while clinical trials are being conducted, FDA is facilitating access to COVID-19 convalescent plasma for use in patients with serious or immediately life-threatening COVID-19 infections through the process of single patient emergency Investigational New Drug Applications eINDs for Individual patients under 21 CFR 312.310. This process allows the use of an investigational drug for the treatment of an individual patient by a licensed physician upon FDA authorization. This does not include the use of COVID-19 convalescent plasma for the prevention of infection.
Healthcare providers interested in the emergency use of investigational COVID-19 convalescent plasma under a single patient emergency IND should consider the following:
COVID 19 Convalescent Plasma
COVID-19 convalescent plasma must only be collected from recovered individuals if they are eligible to donate blood
Required testing must be performed and the donation must be found suitable
Additional considerations for donor eligibility should be addressed, as follows:
Prior diagnosis of COVID-19 documented by a laboratory test
Complete resolution of symptoms at least 14 days prior to donation
Female donors negative for HLA antibodies or male donors
Negative results for COVID-19 either from one or more nasopharyngeal swab specimens or by a molecular diagnostic test from blood. A partial list of available tests can be accessed at
https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations.
Defined SARS-CoV-2 neutralizing antibody titers, if testing can be conducted
The container label of COVID-19 convalescent plasma units must include the following statement, โCaution: New Drug--Limited by Federal or United States law to investigational use."
Eligible patients for use under expanded access provisions:
Must have laboratory-confirmed COVID-19
Must have severe or immediately life-threatening COVID-19, for example:1
Severe disease is defined as:
โข dyspnea,
โข respiratory frequency greate rthan or equal to 30/min,
โข blood oxygen saturation greate rthan or equal to 93%,
โข the partial pressure of arterial oxygen to fraction of inspired oxygen ratio greater than 300, and/or
โข lung infiltrates greater than 50% within 24 to 48 hours
The life-threatening disease is defined as:
โข respiratory failure,
โข septic shock, and/or
โข multiple organ dysfunction or failure
Must provide informed consent
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