Corona COVID-19 SARS-CoV-2
Conditions
Interventions
Ampligen will be administered intranasally via a nasal sprayer. An amount of
250 *L will be administered in each nostril (total volume of 500 *L per dose).
Each individual will receive the same dose
Sponsors
AIM ImmunoTech Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Signed informed consent prior to any study-mandated procedure; 2. Male or female subjects, 18 to 70 years of age, inclusive at screening; 3. Body mass index (BMI) between 18 and 32 kg/m2, inclusive at screening, and with a minimum weight of 50 kg. 4. Participant must be healthy, in the investigator*s clinical judgment, as confirmed by medical history, physical examination, vital signs, ECG and laboratory assessments performed at screening. Repeated laboratory testing may be performed at the discretion of the clinical investigators for spurious results on a case by case basis; 5. Willing to comply with effective contraception during the study if subject is male or women of child bearing potential, up to 90 days after the last dose of study treatment. 6. Has the ability to communicate well with the investigator in the Dutch language and willing to comply with the study restrictions
Exclusion criteria
Exclusion criteria: 1. Evidence of any active or chronic disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would pose an unacceptable risk to the subject in the opinion of the investigator (following a detailed medical history, physical examination, vital signs (systolic and diastolic blood pressure, pulse rate, body temperature) and 12-lead electrocardiogram (ECG). Minor deviations from the normal range may be accepted, if judged by the Investigator to have no clinical relevance; 2. Clinically significant abnormalities, as judged by the investigator, in laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis. In the case of uncertain or questionable results, tests performed during screening may be repeated before randomization to confirm eligibility or judged to be clinically irrelevant for healthy subjects; 3. Positive hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV ab), or human immunodeficiency virus antibody (HIV ab) at screening; 4. Respiratory tract infection (including flu and common cold symptoms) or any febrile illness (>38°celsius) in the period of 3 days before first treatment administration; 5. Presence of respiratory viral infection as determined by respiratory panel on nasal swab at baseline (including positive SARS-CoV-2 PCR test); 6. History of chronic respiratory diseases (e.g. chronic obstructive pulmonary disease, emphysema, chronic rhinitis or sinusitis, asthma or other reactive airway diseases) in adulthood. Childhood asthma and non-active allergic rhinitis (including hay fever) will be permitted at the discretion of the investigator; 7. History of frequent nose bleeds; 8. Significant anatomical nasal abnormalities or other nasal abnormalities that might impact the study executions (including, but not limited to, nasal septal defects, cleft palate, nasal polyps, previous nasal cautery or surgery that impacts study assessments); 9. Immunocompromised (known or expected immune deficiency, disease, or use of medication that may affect the immune system) or evidence of autoimmune disorder (deemed clinically relevant by the investigator); 10. Participation in an investigational drug or device study (last dosing of previous study was within 90 days or 5 half-lives prior to first dosing of this study); 11. History of abuse of addictive substances (alcohol, illegal substances) or current use of more than 21 units of alcohol per week, drug abuse, or regular user of sedatives, hypnotics, tranquillisers, or any other addictive agent; 12. Positive test for drugs of abuse at screening or pre-dose. Drugs test may be repeated; 13. A routine smoker of tobacco products, currently or in the past year. No (incidental) smoking will be allowed in the two weeks prior to first dosing; 14. Use of immunomodulatory drug; including systemic corticosteroids as well as nasal preparations within 30 days before first dosing. Low dose topical use of corticosteroids will be permitted. Other exceptions will only be made if the rationale is clearly documented by the investigator; 15. Receipt of any vaccine within 1 week prior to IMP administration, or planning to get vaccinated during the study; 16. Therapy with interferons, inte
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| N.A. | — |
Primary
| Measure | Time frame |
|---|---|
| * Frequency of local Treatment-Emergent Adverse Events (TEAEs) * Frequency of systemic Treatment-Emergent Adverse Events (TEAEs) * Frequency of any serious adverse events (SAEs) * Frequency of any withdrawals due to Adverse Events (AEs) * Frequency of any Dose Limiting Toxicities (DLTs) * Change in laboratory values, vital signs, physical examination findings (including nasal and oral examination) * Nasal pain assessed by visual analogue scale (VAS) * Integrity of the nasal mucosa by anterior rhinoscopy * Levels of mucosal cytokines * Characterization of mucosal immune cells | — |
Countries
Netherlands
Outcome results
None listed