COVID-19 - Brazilian Health Regulatory Agency (ANVISA) authorizes Domp?'s REPAVID-19, a Phase 2 Clinical Trial for Treatment of Severe Patients
10 Brazilian centers in S?o Paulo,?Brasilia, Presidente Prudente, Sao Jos? do?Rio Preto, Varginha,?Salvador de Bahia, Crici?ma
The Phase 3 clinical study will be enlarged to the US
MILAN,?Sept. 2, 2020?/PRNewswire/ --?Brazil's Health Regulatory Agency, ANVISA, has greenlighted Domp?'s?REPAVID-19,?Clinical Trial of?Reparixin for Treatment of Severe Covid-19 Patients.
Reparixin inhibits the action of interleukin 8 (IL-8),?one of the inflammatory signaling proteins that is thought to be associated with the lung injury seen in patients with SARS-CoV2 infection. Consequently, this action is aimed to be useful in the treatment of COVID-19 pneumonia patients. The treatment is based on?Reparixin oral tablets 1200 mg TID till 21 days, in case of confirmed improvement after 7 days.
REPAVID-19 will enroll?48 for Phase 2, 111 for Phase 3 with severe COVID-19 pneumonia randomized 2:1 in the Phase 2, and the results will inform the study design for the Phase 3. The study involves a minimum of?10 Brazilian centers. Following successful completion of Phase 2, Domp? has prepared a rapid transition into a Phase 3 program, to begin once data from Phase 2 are positively evaluated, and to be?extended to multiple US centers.
ReferencesREPAVID-19 Clinical Study (DDCM) #25351.664925/2020-86
Brazilian Health Regulatory Agency (ANVISA)?http://portal.anvisa.gov.br/english
Di?rio Oficial da Uni?o?http://www.in.gov.br/autenticidade.html Repavid-19 sites list (City, State) S?o Paulo?(S?o Paulo)
- Instituto do Cora??o do Hospital das Cl?nicas da Faculdade de Medicina de S?o Paulo
- Hospital Vila Nova Star Presidente Prudente?(S?o Paulo)
- Santa Casa de Miseric?rdia de Presidente Prudente Sao Jos? do?Rio Preto?(S?o Paulo)
- Faculdade?de?Medicina de S?o Jos? do Rio Preto Varginha?(Minas Gerais)
- Hospital Humanitas Salvador?(Bahia)
- Hospital da Cidade
- Hospital General Ernesto Sim?es Filho- SESAB
- Hospital S?o Rafael.?Rede D'or?S?o Luiz Brasilia?(Distrito Federal)
- Instituto D'or Pesquisa e Ensino Crici?ma?(Santa Catarina)
- Sociedade Liter?ria e Caritativa Santo Agostinho - Hospital S?o Jos? About Domp?
Domp? is a private, rapidly scaling global biopharmaceutical company founded in?Milan,?Italy. Today, Domp? employs more than 800 employees worldwide and maintains a US commercial operations hub in the?San Francisco Bay Area as well as an R&D presence in?Boston. Medical Affairs Contacts:
medical.info@dompe.com Logo -?https://mma.prnewswire.com/media/1190715/Dompe_Logo.jpg SOURCE Domp? Farmaceutici S.p.A
