A Clinical Study Evaluating Inhaled Aviptadil on COVID-19
Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
This study is a multicenter, prospective, placebo-controlled, comparative, randomized,
double-blind local phase II clinical trial. Duration of study is 18 months. In the study,
patients will be randomized in a ratio of 1: 1 into two arms, standard medical therapy +
placebo versus standard medical therapy + inhaled Aviptadil arms. Randomization will be
carried out by the block randomization method. In the event that patients need intensive care
in the study, the patients will be taken into intensive care unit and excluded from the study
and their treatment will be continued in the intensive care unit as deemed appropriate by the
physician and it is foreseen that inhaled Aviptadil will be used for a period of minimum 7
and maximum 14 days. Aviptadil will be discontinued in patients who do not heal after 14
days. This study includes 8 visits, consisting of a total of 7 physical visits and 1 phone
follow-up visit. The study period will be 6 months for each patient. Patient recruitment is
planned to take 12 months. Study centers will be asked to use investigational products for
their patients who sign the informed consent form for 12 months. The study population will
consist of patients 18 years of age and older with COVID-19 pulmonary involvement and
hospitalized patients.