dc.contributor.author | Chiquete, Erwin | |
dc.contributor.author | Toapanta-Yanchapaxi, Liz | |
dc.contributor.author | Cantu-Brito, Carlos | |
dc.date.accessioned | 2020-05-27T16:16:42Z | |
dc.date.available | 2020-05-27T16:16:42Z | |
dc.date.issued | 2020-05-01 | |
dc.identifier.uri | https://doi.org/10.1101/2020.04.26.20079988 | en_US |
dc.identifier.uri | https://hdl.handle.net/20.500.12663/1615 | |
dc.description.abstract | Background: Coronavirus disease 2019 (COVID-19) is the systemic entity caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that may cause death through severe atypical pneumonia and acute lung injury. Valproic acid (VPA) has shown anti-inflammatory activity and mild intrinsic antiviral effect. These properties warrant the study of VPA as a possible active treatment in persons with severe COVID-19. Methods: Consecutive adult patients needing invasive mechanical ventilation (IMV) will be given intravenous (i.v.) VPA at a starting dose of 20 mg/kg/day and up to 60/kg/day (in 60 min i.v. infusions in 250 mL normal saline) as needed to reach plasma VPA concentrations of 50-100 mcg/mL (measured every 72 h). These patients will be followed-up for 10 days for the primary outcome and for a further period of 30 days after treatment completion for the secondary outcome of recurrence. The primary study outcome is the reduction in the case fatality rate of at least 50% after 10 days of treatment (as compared with natural history). Secondary outcomes are the reduction of length of stay (LOS) of at least 50%, as well as COVID-19 recurrence at 30-day follow-up. The most important safety outcomes are acute liver failure, acute pancreatitis, and thrombocytopenia. Conclusion: Although long-term adverse effects and even pro-inflammatory consequences have been reported with the chronic use of VPA, given the urgent need for a drug against COVID-19 to shorten the high mortality and LOS, the study of VPA is justified from a scientific standpoint. | en_US |
dc.language | English | en_US |
dc.subject | COVID-19 | en_US |
dc.subject | Coronavirus | en_US |
dc.subject | Infectious Diseases | en_US |
dc.subject | Proof of Concept Study | en_US |
dc.subject | Valproic Acid | en_US |
dc.subject | SARS-CoV | en_US |
dc.subject | Betacoronavirus | en_US |
dc.title | Methods of An Open-Label Proof-Of-Concept Trial of Intravenous Valproic Acid for Severe COVID-19 | en_US |
eihealth.country | Global (WHO/OMS) | en_US |
eihealth.category | Candidate therapeutics RD | en_US |
eihealth.type | Published Article | en_US |
eihealth.maincategory | Save Lives / Salvar Vidas | en_US |
dc.relation.ispartofjournal | medRxiv | en_US |