Clinical trial: Evaluating the Effect of NT-I7, a Long Acting Interleukin-7, to Increase Lymphocyte Counts and Enhance Immune Clearance of SARS-CoV-2 (COVID-19) (NCT04498325)

Eligibility criteria:
Inclusion Criteria:

          -  Tested PCR positive for SARS-CoV-2by nasopharyngeal swab, oropharyngeal swab, or
             saliva.

          -  Mild COVID-19, defined as WHO Ordinal Scale <4 .

          -  Respiratory rate < 20 bpm, HR < 90 bpm, and SpO2 > 93% on room air at sea level.

          -  Absolute lymphocyte count (ALC) < 1500 cells/mm3 at the time of screening.

          -  AST/ALT ≤ 3.0 x ULN, total bilirubin ≤ 1.5 x ULN (except if due to Gilbert's
             syndrome).

             -≥ 18 years of age.

          -  First day of treatment must be no more than 10 days from onset of COVID-19 symptoms.

          -  Must be willing to be closely monitored in the hospital or in an alternate setting
             (e.g. clinical trial unit) for at least the first 7 days (±2 days allowed) following
             NT-I7/placebo injection.

          -  Individuals of reproductive potential must agree to either abstinence or use of at
             least one study-approved form of contraception when engaging in sexual activities that
             can result in pregnancy from the time of screening through 60 days for female and 120
             days for male after study agent administration. Acceptable forms of contraception for
             this study are male or female condoms, diaphragms or cervical caps with a spermicide,
             or non-hormonal intrauterine devices.

          -  Patients with factors or concomitant illness associated with higher risk of mortality
             due to COVID-19 (such as older age, hypertension, diabetes, and/or COPD) are eligible.

          -  Able to understand and willing to sign an IRB approved written informed consent
             document.

        Exclusion Criteria:

          -  Receiving any other investigational agents which may affect patient's lymphocyte
             counts. Note: There is no evidence that chloroquine or hydroxychloroquine could affect
             lymphocyte counts. Thus, chloroquine or hydroxychloroquine use is not an exclusion
             criteria for this study. Additionally, it is permissible for potential participants to
             have received investigational or off-label agents for COVID-19 prior to or during
             study participation.

          -  Pregnant or breastfeeding women are excluded from this study because NT-I7 has not
             been evaluated regarding its potential for teratogenic or abortifacients effects.
             There is a potential risk for adverse events in nursing infants secondary to treatment
             of the mother with the study drug; therefore, breastfeeding should be discontinued if
             the mother is treated with NT-I7.

          -  Transferred from ICU to the floor.

          -  Requiring dialysis.

          -  Shortness of breath or known hypoxia (defined as PaO2/FiO2 ≤ 300 mmHg), or signs of
             serious lower airway disease.

          -  Evidence of ARDS, SIRS/shock, or cardiac failure.

          -  Elevated inflammatory markers such as CRP > 2 x ULN, LDH > 2 x ULN, D-dimer > 2 x ULN,
             ferritin > ULN, or IL-6 > ULN (when available).

          -  Any established diagnosis of autoimmune disease requiring systemic treatment EXCEPT
             for vitiligo or endocrine disease (such as diabetes, thyroid disease, and adrenal
             disease) controlled by replacement therapy.

          -  Receipt of live attenuated vaccine within 30 days before the study treatment. Examples
             of live vaccines include, but are not limited to, the following: measles, mumps,
             rubella, chicken pox, yellow fever, rabies, Bacillus Calmette-Guérin (BCG), Zoster,
             and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed
             virus vaccines and are allowed; however, intranasal influenza vaccines (e.g. FluMist)
             are live attenuated vaccines and are not allowed.
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? Entailment