Trial of Famotidine & N-Acetyl Cysteine for Outpatients With COVID-19

Prisma Health-Upstate

Status and phase: Terminated; Phase 1

Conditions: Covid19

Treatments: Drug: N-Acetyl cysteine; Drug: Famotidine

Study type: Interventional

Funder types: Other

Identifiers

NCT04545008

Pro00100394

Details and patient eligibility

About

The purpose of this trial is to assess the safety and toxicity profile of the combination of famotidine and oral n-acetyl cysteine in adult outpatients with newly diagnosed SARS-CoV-2 infection.

Full description

This is a phase I trial enrolling subjects with newly diagnosed SARS-CoV-2 infection who do not require hospitalization. Exclusion criteria have been written to exclude patients who would be expected to have increased risk from either medication alone. Subjects will be assigned a dose combination of famotidine and n-acetyl cysteine. In addition to assessing the safety and toxicities profiles of the combination of drugs we will be measuring certain endpoints to assess possible efficacy. These endpoint include the following: rates of hospitalization; time to complete remission of symptoms, e.g, fever, respiratory symptoms, etc.; severity of symptoms with validated survey instruments; cytokine values in serum and urine; and markers of inflammation and oxidative stress.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 18
• performance of a SARS-CoV-2 test within 1 day of enrollment, N.B., must be positive to proceed to treatment phase of the trial

Exclusion criteria

• All patients under 18
• Known allergy to N-Acetyl Cysteine
• Known allergy to famotidine or other H2-receptor antagonists
• Pregnant or Nursing Mothers
• Laboratory Evidence or History of Renal Impairment (eGFR < 30 mL/min/1.73 m2)
• Taking H2-receptor antagonists, hydroxychloroquine or chloroquine.
• Patient has been admitted to the hospital prior to study enrollment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2 participants in 12 patient groups

Low Dose N-Acetyl Cysteine Alone

Experimental group

Description:

N-Acetyl Cysteine 600 mg three times daily

Treatment:

Drug: N-Acetyl cysteine

Medium Dose N-Acetyl Cysteine

Experimental group

Description:

N-Acetyl Cysteine 1,200 mg three times daily

Treatment:

Drug: N-Acetyl cysteine

Low Dose N-Acetyl Cysteine and Low Dose Famotidine

Experimental group

Description:

N-Acetyl Cysteine 600 mg three times daily Famotidine 20 mg three times daily

Treatment:

Drug: Famotidine

Drug: N-Acetyl cysteine

High Dose N-Acetyl Cysteine Alone

Experimental group

Description:

N-Acetyl Cysteine 1,800 mg three times daily

Treatment:

Drug: N-Acetyl cysteine

Medium Dose N-Acetyl Cysteine and Low Dose Famotidine

Experimental group

Description:

N-Acetyl Cysteine 1,200 mg three times daily Famotidine 20 mg three times daily

Treatment:

Drug: Famotidine

Drug: N-Acetyl cysteine

Low Dose N-Acetyl Cysteine and Medium Dose Famotidine

Experimental group

Description:

N-Acetyl Cysteine 600 mg three times daily Famotidine 40 mg three times daily

Treatment:

Drug: Famotidine

Drug: N-Acetyl cysteine

High Dose N-Acetyl Cysteine and Low Dose Famotidine

Experimental group

Description:

N-Acetyl Cysteine 1,800 mg three times daily Famotidine 20 mg three times daily

Treatment:

Drug: Famotidine

Drug: N-Acetyl cysteine

Medium Dose N-Acetyl Cysteine and Medium Dose Famotidine

Experimental group

Description:

N-Acetyl Cysteine 1,200 mg three times daily Famotidine 40 mg three times daily

Treatment:

Drug: Famotidine

Drug: N-Acetyl cysteine

Low Dose N-Acetyl Cysteine and High Dose Famotidine

Experimental group

Description:

N-Acetyl Cysteine 600 mg three times daily Famotidine 80 mg three times daily

Treatment:

Drug: Famotidine

Drug: N-Acetyl cysteine

High Dose N-Acetyl Cysteine and Medium Dose Famotidine

Experimental group

Description:

N-Acetyl Cysteine 1,800 mg three times daily Famotidine 40 mg three times daily

Treatment:

Drug: Famotidine

Drug: N-Acetyl cysteine

Medium Dose N-Acetyl Cysteine and High Dose Famotidine

Experimental group

Description:

N-Acetyl Cysteine 1,200 mg three times daily Famotidine 80 mg three times daily

Treatment:

Drug: Famotidine

Drug: N-Acetyl cysteine

High Dose N-Acetyl Cysteine and High Dose Famotidine

Experimental group

Description:

N-Acetyl Cysteine 1,800 mg three times daily Famotidine 80 mg three times daily

Treatment:

Drug: Famotidine

Drug: N-Acetyl cysteine