COVID-19 - Brazilian Health Regulatory Agency (ANVISA) authorizes Dompé's REPAVID-19, a Phase 2 Clinical Trial for Treatment of Severe Patients
- 10 Brazilian centers in São Paulo, Brasilia, Presidente Prudente, Sao José do Rio Preto, Varginha, Salvador de Bahia, Criciùma
- The Phase 3 clinical study will be enlarged to the US
MILAN, Sept. 2, 2020 /PRNewswire/ -- Brazil's Health Regulatory Agency, ANVISA, has greenlighted Dompé'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, Dompé 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.
REPAVID-19 Clinical Study (DDCM) #25351.664925/2020-86
Brazilian Health Regulatory Agency (ANVISA) http://portal.anvisa.gov.br/english
Diário Oficial da União http://www.in.gov.br/autenticidade.html
Repavid-19 sites list (City, State)
São Paulo (São Paulo)
- Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina de São Paulo
- Hospital Vila Nova Star
Presidente Prudente (São Paulo)
- Santa Casa de Misericórdia de Presidente Prudente
Sao José do Rio Preto (São Paulo)
- Faculdade de Medicina de São José do Rio Preto
Varginha (Minas Gerais)
- Hospital Humanitas
- Hospital da Cidade
- Hospital General Ernesto Simões Filho- SESAB
- Hospital São Rafael. Rede D'or São Luiz
Brasilia (Distrito Federal)
- Instituto D'or Pesquisa e Ensino
Criciùma (Santa Catarina)
- Sociedade Literária e Caritativa Santo Agostinho - Hospital São José
Dompé is a private, rapidly scaling global biopharmaceutical company founded in Milan, Italy. Today, Dompé 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:
View original content to download multimedia:http://www.prnewswire.com/news-releases/covid-19---brazilian-health-regulatory-agency-anvisa-authorizes-dompes-repavid-19-a-phase-2-clinical-trial-for-treatment-of-severe-patients-301123021.html
SOURCE Dompé Farmaceutici S.p.A