COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04402060

Apellis Clinical Trial Information Line

clinicaltrials@apellis.com

2020-05-26

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: - be at least 18 years of age at time of informed consent - diagnosis of active sars cov 2 infection using viral rna or viral antigen within 7 days of screening respiratory failure requiring oxygen supplementation or either invasive or noninvasive mechanical ventilation with pao2/fio2 ratio >100 mm hg. respiratory failure cannot be fully explained by cardiac failure or fluid overload.

- treatment with immune checkpoint inhibitors, or other immunomodulators within 3 months prior to study enrollment (however, treatment with convalescent plasma, steroids, il-6 inhibitors, and antiviral agents is not excluded) - active bacterial, fungal, or parasitic infection - history of neuromuscular degenerative disease (eg, amyotrophic lateral sclerosis, duchenne muscular dystrophy, or multiple sclerosis) - current participation in an interventional clincial trial - subjects who have, at screening, been on mechanical ventilation for >7 days have evidence of kidney and liver failure at screening - have a hereditary complement deficiency - pregnancy or breastfeeding

2

Apellis Pharmaceuticals, Inc.

18

100

Brazil;United States

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

72

Number of Subjects Who Experienced Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs

None

Phase 1/Phase 2

[{"arm_notes": "", "treatment_id": 111, "treatment_name": "Apl-9", "treatment_type": "Immunosuppressants", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]