A Study to Evaluate Ampion in Patients With Prolonged Respiratory Symptoms Due to COVID-19 (Long COVID)

NCT04880161 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: AP-018
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase I study to evaluate the safety and efficacy of inhaled Ampion on patients with prolonged respiratory symptoms due to COVID-19 (Long COVID).

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• The Number of Participants With Treatment Emergent Adverse Events of Ampion Compared to Placebo

  Number of subjects with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of treatment of inhalation Ampion compared to Placebo. AEs were assessed based on symptoms as a severity rating of mild, moderate, or severe. The relationship between AE and study drug was determined as either unrelated, possibly related, or related. SAEs are defined as resulting death, life threatening, requires prolonged hospitalization, results in persistent or significant disability/incapacity, or results in congenital anomaly/birth defect.

  Baseline to Day 28

Study Arms (2)

Active

EXPERIMENTAL

Ampion

Biological: Ampion

Control

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

Ampion BIOLOGICAL

Inhaled Ampion

Active

Placebo OTHER

Inhaled Placebo

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female adults: ≥ 18 years.
• Must have a clinical diagnosis of COVID-19 at least 4 weeks prior to the screening date, with at least one of clinical symptoms (e.g., fever ≥ 38°C, fatigue, cough) and a positive result by the reverse-transcription polymerase chain reaction (RT-PCR) testing or equivalent.
• Experiencing at least two COVID-19 respiratory symptoms with a score of two or higher using the FDA Assessment of 14 Common COVID-19-Related Symptoms questionnaire for at least 4 weeks (28 days) after initial positive COVID-19 diagnosis: cough, sore throat, runny/stuffy nose, shortness of breath (difficulties breathing), tightness of chest, low exercise tolerance.
• Able to bear weight and ambulate a minimum of 10 meters distance.
• Women of childbearing potential and their partner must agree to use at least one highly effective method of contraception (e.g., hormonal contraceptives \[implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings\], intrauterine devices, bilateral tubal occlusion, or sexual abstinence) for the duration of the study.
• Informed consent obtained from the patient or the patient's legal representative.

You may not qualify if:

• Subjects who require hospitalization.
• Patient has severe chronic obstructive or restrictive pulmonary disease (COPD) as defined by prior pulmonary function tests, chronic renal failure, or significant liver abnormality (e.g., cirrhosis, transplant, etc.).
• History of Chronic Fatigue Syndrome prior to COVID-19 infection.
• Patient is on chronic immunosuppressive medication.
• Patient requires surgery that could be life-threatening within the study window.
• Patient has known pregnancy or is currently breastfeeding.
• Participation in a trial such that enrollment in this study would fall within the time frame of the half-life of the other investigational product(s).
• Clinically significant findings via electrocardiogram (ECG), including acute myocardial infarction, acute ischemic changes, atrial fibrillation, atrial flutter, paced rhythms in individuals who have undergone permanent pacemaker placement, evidence of prior infarction, unchanged stable conduction abnormalities e.g., right bundle branch block, or any other finding which does not significantly impact mortality.
• Pre-existing co-morbid condition(s) preventing outcome assessments, e.g. disease or condition that would prevent ability to transfer and walk for 6 minutes, prior to confirmed COVID-19 diagnosis (assisted walking devices are acceptable)
• As a result of the medical review and screening investigation, the Principal Investigator considers the patient unfit for the study.

Sponsors & Collaborators

• Ampio Pharmaceuticals. Inc.: lead

Study Sites (1)

Ampio Pharmaceuticals

Englewood, Colorado, 80112, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

aspartyl-alanyl-diketopiperazine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr. Howard Levy / Chief Medical Officer
• Organization: Ampio Pharmaceuticals

clinicaltrials@ampiopharma.com

17204376500

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: May 10, 2021
• Study Start: July 26, 2021
• Primary Completion: December 22, 2021
• Study Completion: February 21, 2022
• Last Updated: September 21, 2023
• Results First Posted: September 21, 2023

Record last verified: 2022-05

Locations

US (1)