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10 Brazilian centers in Sao Paulo, Brasilia, Prudent Presidente, Sao José do Rio Preto, Varginha, Salvador de Bahia, Crici-ma
Phase 3 trial to be extended to the U.S.
MILAN, 2 September 2020 / PRNewswire / – Brazil’s Health Regulatory Agency, ANVISA, approved Dompé’s REPAVID-19 clinical trial, a clinical trial of reparixin for the treatment of patients with severe covid-19.
Reparixin inhibits the action of interleukin 8 (IL-8), one of the inflammatory signaling proteins that is thought to be related to lung injury in patients with SARS-CoV2 infection, so this action is intended to be useful in treating patients with COVID-19 pneumonia. Treatment is based on oral reparixin tablets 1200 mg TID up to 21 days, in case of showing improvement after 7 days.
REPAVID-19 will recruit 48 for Phase 2, 111 for Phase 3 with severe pneumonia in randomized COVID-19 2:1 in Phase 2, and the effects will indicate the design of Phase 3.The result is a minimum of 10 Brazilians After the successful final touch of Phase 2, Dompé is ready for an immediate transition to a Phase 3 program, starting once Knowledge of Phase 2 has been positively and prolongedly evaluated to several US centers.But it’s not the first time
References Clinical Study REPAVID-19 (DDCM) – 25351.664925 / 2020-86 Brazilian Health Regulatory Agency (ANVISA) http://portal.anvisa.gov.br/englishDiário Oficial da Unao http://www.in.gov.br/ authenticidade .html
Repavid-19 List (City, State)
Sao Paulo, Sao Paulo – Instituto do Coracao do Hospital das Clunicas da Faculdade de Medicina de Sao Paulo – Hospital Vila Nova Star
Presidente Prudente (Sao Paulo) – Santa Casa de Miseric-rdia de Presidente Prudente
Sao José do Rio Preto (Sao Paulo) – Faculdade de Medicina de Sao José do Rio Preto
Varginha (Minas Gerais) – Hospital Humanitas
Salvador (Bahia) – Hospital da Cidade – Ernesto Sims Filho- General Hospital SESAB – Hospital Sao Rafael. Rede D’Or Sao Luiz
Brasilia (Federal District) – D’or Pesquisa e Ensino Institute
Crici-ma (Santa Catarina) – Sociedade Literria e Caritativa Santo Agostinho – Hospital San José
Dompé is a fast-growing, global personal biopharmaceutical company founded in Milan, Italy.Today, Dompé employs more than 800 international people and maintains a U.S. commercial operations center.But it’s not the first time In the San Francisco Bay Area and a presence of R.
Contacts for Matters: [email protected]
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SOURCE Dompé Farmaceutici S.p.A