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Complement Inhibitor

Danicopan for Coronavirus

Phase 2

Waitlist Available

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up days 1, 3, 5, 8, 11, 15, 22, 29

Summary

This trial is testing whether adding a new drug, danicopan, to an existing treatment, remdesivir, can improve outcomes for hospitalized adults with COVID-19. Remdesivir helps reduce virus levels, and danicopan may enhance this effect. Remdesivir is an antiviral drug that has been shown to reduce recovery time in hospitalized COVID-19 patients and is approved by the FDA for treating both hospitalized and nonhospitalized COVID-19 patients.

Eligible Conditions

Coronavirus

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ days 1, 3, 5, 8, 11, 15, 22, 29

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~days 1, 3, 5, 8, 11, 15, 22, 29

This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1, 3, 5, 8, 11, 15, 22, 29 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 8

Secondary study objectives

14-day Participant Mortality

28-day Participant Mortality

59-day Participant Mortality

+38 more

Side effects data

From 2024 Phase 3 trial • 88 Patients • NCT04469465

24%

Pyrexia

20%

COVID-19

15%

Headache

13%

Nasopharyngitis

Asthenia

Urinary tract infection

Fatigue

Pain in extremity

Breakthrough haemolysis

Cough

Non-cardiac chest pain

Nausea

Productive cough

Dizziness

Back pain

Contusion

Haemolysis

Anaemia

Thrombocytopenia

Hypertension

Abdominal pain

Vomiting

Stent-graft endoleak

Haemoglobin decreased

Platelet count decreased

Pulmonary embolism

Insomnia

Chromaturia

Dyspnoea

Diarrhoea

Arthralgia

Tachycardia

Pulmonary haemorrhage

Invasive ductal breast carcinoma

100%

80%

60%

40%

20%

Study treatment Arm

Placebo-Danicopan (TP2)

Danicopan-Danicopan (LTE)

Danicopan-Danicopan (TP2)

Placebo-Danicopan (LTE)

Danicopan (TP1)

Placebo (TP1)

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Remdesivir + Danicopan (>/= 70 years)Experimental Treatment2 Interventions

For participants \>/= 70 years, 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 300 mg oral (PO) (or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan, followed by 200 mg 4 times daily (QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 200 mg 3 times daily (TID) for 2 days, followed by 200 mg twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). Total danicopan participants, N=100.

Group II: Remdesivir + Danicopan (< 70 years)Experimental Treatment2 Interventions

For participants \< 70 years, 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) (or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg 3 times daily (TID) for 2 days, followed by 250 mg twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). Total danicopan participants, N=100.

Group III: Remdesivir + Placebo (< 70 years)Active Control2 Interventions

For participants \< 70 years, 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) (or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg 3 times daily (TID) for 2 days, followed by 250 mg twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). Total danicopan matching placebo participants, N=100.

Group IV: Remdesivir + Placebo (>/= 70 years)Active Control2 Interventions

For participants \>/= 70 years, 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 300 mg oral (PO) (or via nasogastric \[NG\] or gastrostomy \[G\] tube) of loading dose danicopan matching placebo followed by 200 mg 4 times daily (QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 200 mg 3 times daily (TID) for 2 days, followed by 200 mg twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). Total danicopan matching placebo participants, N=100.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Danicopan

2020

Completed Phase 3

~680

Remdesivir

2020

Completed Phase 3

~21440