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Trial - NCT05184218


Column Value
Trial registration number NCT05184218
Full text link
Last imported at : Jan. 12, 2022, 9 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT05184218

First author
Last imported at : Oct. 18, 2022, 12:35 p.m.
Source : ClinicalTrials.gov

Not reported

Contact
Last imported at : Oct. 18, 2022, 12:35 p.m.
Source : ClinicalTrials.gov

Not reported

Registration date
Last imported at : Jan. 12, 2022, 9 a.m.
Source : ClinicalTrials.gov

2022-01-11

Recruitment status
Last imported at : Oct. 18, 2022, 12:35 p.m.
Source : ClinicalTrials.gov

Terminated

Study design
Last imported at : Jan. 12, 2022, 9 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Jan. 12, 2022, 9 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Jan. 12, 2022, 9 a.m.
Source : ClinicalTrials.gov

Sequential assignment

Masking
Last imported at : Jan. 12, 2022, 9 a.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : Jan. 12, 2022, 9 a.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Jan. 12, 2022, 9 a.m.
Source : ClinicalTrials.gov

healthy volunteers inclusion criteria: is male or non-pregnant female adult ≥ 18 and ≤ 55 years of age has a body mass index (bmi) < 35 kg/m2. is healthy as determined by medical history and physical examination agrees to use contraception through 3 months after the last dose of igm-6268

Exclusion criteria
Last imported at : Jan. 12, 2022, 9 a.m.
Source : ClinicalTrials.gov

receipt of any covid-19 vaccine during this study and follow-up period prior positive sars-cov2 test hepatitis b virus (hbv), hepatitis c virus (hcv), or uncontrolled human immunodeficiency virus (hiv) infection use of any nasally administered drug mild-moderate covid patients inclusion criteria: is male or non-pregnant female adult ≥ 18 and ≤ 55 years of age agrees to use contraception through 3 months after the last dose of igm-6268 agrees to the collection of blood, urine, saliva, and nasopharyngeal samples, per protocol. signs and symptoms of mild to moderate covid-19 but not requiring hospitalization has a laboratory-confirmed sars-cov-2 infection as determined by fda-authorized antigen or naat diagnostic assay during the period of 72 hours prior to enrollment.

Number of arms
Last imported at : Jan. 12, 2022, 9 a.m.
Source : ClinicalTrials.gov

9

Funding
Last imported at : Jan. 12, 2022, 9 a.m.
Source : ClinicalTrials.gov

IGM Biosciences, Inc.

Inclusion age min
Last imported at : Jan. 12, 2022, 9 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Jan. 12, 2022, 9 a.m.
Source : ClinicalTrials.gov

55

Countries
Last imported at : Feb. 9, 2022, 3 p.m.
Source : ClinicalTrials.gov

South Africa

Type of patients
Last imported at : Jan. 12, 2022, 9 a.m.
Source : ClinicalTrials.gov

Mild/moderate disease at enrollment

Severity scale
Last imported at : Jan. 12, 2022, 9 a.m.
Source : ClinicalTrials.gov

2: Mild/moderate disease at enrollment

Total sample size
Last imported at : Oct. 18, 2022, 12:35 p.m.
Source : ClinicalTrials.gov

26

primary outcome
Last imported at : Jan. 12, 2022, 9 a.m.
Source : ClinicalTrials.gov

Safety & tolerability of IGM-6268 by assessing the number, severity, and type of adverse events per CTCAE 5.0

Notes
Last imported at : Jan. 12, 2022, 9 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Jan. 12, 2022, 9 a.m.
Source : ClinicalTrials.gov

Phase 1

Arms
Last imported at : Jan. 12, 2022, 9 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "1 mg;intranasal and intraoral;once per day for 5 days", "treatment_id": 2117, "treatment_name": "Igm 6268", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "3.75 mg;intranasal and intraoral;once per day for 5 days", "treatment_id": 2117, "treatment_name": "Igm 6268", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "7.5 mg;intranasal and intraoral;once per day for 5 days", "treatment_id": 2117, "treatment_name": "Igm 6268", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "7.5 mg;intranasal and intraoral;twice a day for 5 days", "treatment_id": 2117, "treatment_name": "Igm 6268", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "7.5 mg;intranasal and intraoral;once per day for 5 days", "treatment_id": 2117, "treatment_name": "Igm 6268", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "7.5 mg;intranasal and intraoral;twice per day for 5 days", "treatment_id": 2117, "treatment_name": "Igm 6268", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "7.5 mg;intranasal and intraoral;once or twice per day for 5 days", "treatment_id": 2117, "treatment_name": "Igm 6268", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]