Clinical trial: Phase 3 Inhaled Novaferon Study in Hospitalized Patients With Moderate to Severe COVID-19 (NCT04669015)

Eligibility criteria:
Inclusion Criteria:

          -  Signed informed consent form by any patient capable of giving consent, or, when the
             patient is not capable of giving consent, by his or her legal/authorized
             representatives prior to initiation of any study procedures.

          -  Men and women, ≥18 years of age at time of enrollment.

          -  Laboratory-confirmed diagnosis of SARS-CoV-2 infection as determined by PCR, or other
             health authority-approved commercial assay or other validated public health assay in
             any specimen within 72 hours prior to randomization (point-of-care viral infection
             test allowable if RT-PCR test result not available at the time of screening).

          -  Less than or equal to 12 days from COVID-19 symptom onset to starting treatment.

               -  Symptoms are defined as one or more of the following: cough, fever, shortness of
                  breath, chest pain, abdominal pain, nausea/vomiting, diarrhea, body aches,
                  weakness/fatigue, chills/sweating, headache, confusion, sore throat, runny
                  nose/congestion, loss of taste or smell, or any other COVID-19 symptoms as
                  determined by the Investigator.

          -  Hospitalized for no more than 4 days duration, and:

               -  requiring supplemental oxygen by mask or tongs, or ii) non-invasive ventilation
                  or iii) high-flow oxygen (WHO category 4 or 5)

          -  Female patients participating in this study must agree to avoid becoming pregnant and
             have a negative pregnancy test prior to randomization. Male patients must agree to use
             appropriate contraceptive methods to prevent pregnancy with their partner(s), during
             the study and up to post 30 days after the last dose of study drug. Female patients
             must be:

               -  unable to have children (e.g., post-menopausal*, bilateral tubal ligation,
                  hysterectomy, bilateral oophorectomy) or where the partner is sterile (e.g.,
                  vasectomy) OR

               -  willing to remain abstinent (not engage in sexual intercourse for the duration of
                  the screening period and throughout the study, and for 30 days after the last
                  dose) OR

               -  willing to use two effective barrier methods of birth control (partner using
                  condom and female using IUD, hormonal or nonhormonal contraceptive, diaphragm
                  plus spermicide, or contraceptive sponge)

        Exclusion Criteria:

          -  1. Known hypersensitivity or intolerance to Interferon (IFN) or Novaferon or any
             excipient(s) of Novaferon, including pre-existing allergy or hypersensitivity to
             ampicillin.

          -  Currently undergoing invasive mechanical ventilation (including venous ECMO).

          -  Inability to use a nebulizer with a mouthpiece.

          -  ALT/AST > 5 times the upper limit of normal or a history of decompensated cirrhosis.

          -  Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30 mL/min/
             1.73m2).

          -  In the opinion of the Investigator, progression to death is imminent and inevitable
             within the next 48 - 72 hours, irrespective of the provision of treatment.

          -  In the opinion of the Investigator, progression to mechanical ventilation is imminent
             and inevitable within the next 24 hours, irrespective of the provision of treatment.

          -  Possibility of the patient being discharged from hospital within 24 hours.

          -  Participation in other anti-COVID-19 therapeutic or interventional trials. Patients
             may, at the discretion of the Investigator, participate in other non-interventional
             COVID-19 studies.

          -  Current use of other antiviral therapy (e.g. remdesivir, etc.) or other experimental
             therapy, including anti-inflammatory agents, convalescent plasma, or
             hydroxychloroquine

          -  Has received, or has a plan to receive within the 28 day treatment period, a
             SARS-CoV-2 vaccine.

          -  Use of immunomodulatory drugs at, or within 3 months prior to, enrollment; use of
             chronic oral corticosteroids for a non-COVID-19-related condition at a dose higher
             than prednisone 20 mg (or equivalent) per day for the preceding 4 weeks.

          -  Other known active infections or other clinical conditions (e.g. chronic obstructive
             pulmonary disease) that contraindicate aerosolized inhalation; coexisting pneumonia is
             allowed.

          -  Patients with current or prior psychiatric illness, seizure disorders, retinal
             autoimmune disorders, pre-existing severe cardiovascular disease and patients with
             prior transplants.

          -  Females who are breast-feeding, lactating, pregnant or intending to become pregnant.

          -  Positive for hepatitis B, hepatitis C or uncontrolled HIV
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): The patient is a 38-year-old man with cough and body ache that started 3 days ago.  He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx.

Patient description (patient's own words): I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat.

Does the patient match the trial criteria? Contradiction