Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Neutrolis
Age
18–99
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Healthy volunteers:
Male or female, non-smoker, ≥18 and ≤55 years of age, with Body Mass Index (BMI) \> 18.5 and \< 32.0 kg/m2
Healthy with no clinically significant findings, determined by medical evaluation (medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations) at Screening
Subject is able to understand and is willing to comply with all study requirements, and willing to follow the instructions of the study staff.
Subject voluntarily agrees to participate in this study.
Male or female, non-smoker, ≥18 years of age.
Participant has active laboratory-confirmed SARS-CoV-2 infection.
Participant must be hospitalized for COVID-19 pneumonia.
Ability to provide informed consent personally, or by a legally acceptable representative if the participant is unable to do so.
You may not be if
Pregnancy, nursing, and/or breastfeeding.
Study participant has a history of an anaphylactic reaction.
Subject has used an investigational drug within 30 days (or 5 half-lives whichever is longer) prior to the first dose of study drug.
Has received any prescription or nonprescription over-the-counter (except occasional use of acetaminophen, paracetamol or ibuprofen) medication, topical medications, vitamins, dietary or herbal during the last 14 days or 5 half-lives, whichever is longer.
Subject has a positive urine test for drugs of abuse at the screening visit or admission.
Regular consumption of alcohol within 6 months prior to Screening or use of illicit substances within 3 months prior to screening.
Subject has positive test for SARS-CoV-2 infection, human immunodeficiency virus (HIV), chronic or active hepatitis B, or active hepatitis C.
Donation or loss of blood or plasma within 4 weeks prior to initial dosing.
Subject has a history or current evidence of a serious and/or unstable cardiovascular, respiratory, gastrointestinal, hematologic, autoimmune, mental or other medical disorder, including cirrhosis or malignancy; a history of a psychiatric disorder that will affect the subject's ability to participate in the study.
Subject has a clinically relevant abnormal ECG; abnormal laboratory values.
Subject has hypertension.
COVID-19 patients:
Pregnancy, nursing, and/or breastfeeding.
History of an anaphylactic reaction.
In the opinion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments.
Severely immune-compromised participants.
Participant known to test positive for human immunodeficiency virus (HIV), chronic or active hepatitis B, or active hepatitis C.
Any other clinical conditions that in the opinion of the Investigator would make the participants unsuitable for the study.
Prior treatment with any investigational drug therapy against coronavirus infection within 5 half-lives, prior to enrollment
Participants who have received an experimental (or, in future, potentially a licensed) immunization or remdesivir against coronavirus remain eligible.
Participation in another clinical study with the study intervention administered from 30 days or 5 half-lives whichever is longer.
Anticipated transfer to another hospital which is not a study site during the intervention period.
Clareo Health | Phase 1 Study to Assess Safety, Tolerability, PD, PK, Immunogenicity of IV NTR-441 Solution in Healthy Volunteers and COVID-19 Patients
