Safety, tolerability, bioavailability, and biological activity of inhaled interferon-α2b in healthy adults: The IN2COVID phase 1 randomized trial
Bibliographic record
Abstract
Aim: Interferons (IFNs) have been identified as a potential treatment alternative for Coronavirus Disease 19 (COVID-19). This study assessed the safety, tolerability, bioavailability, and biological activity of inhaled interferon-α2b (IFN-α2b) in healthy adults. Methods: A double-blind, randomized, phase 1 clinical trial was conducted with two cohorts of healthy subjects aged 18-50 years old. The first cohort received 2.5 MIU of inhaled IFN-α2b twice daily for 10 days (n=6) or placebo (n=3); the second cohort received 5.0 MIU of inhaled IFN-α2b in a similar scheme (n=6) or placebo (n=3). The first two doses were administered in an Emergency Department, then participants completed their treatment at home. Safety was measured through vital signs, new symptoms, and laboratory tests. Tolerability was measured as the participant´s treatment acceptability. Bioavailability and biological activity were measured from serum IFNα levels and real-time quantitative PCR of interferon-induced genes in blood before and after treatments. Results: Exposure to inhaled IFN-α2b at 2.5 MIU or 5 MIU doses did not produce significant changes in participant vital signs, or elicit new symptoms, and standard hematological and biochemical blood measurements were comparable to those recorded in individuals who received placebo. All adverse events were mild or moderate and did not require medical care. Participants reported very high tolerability. A dose-dependent mild increase in serum IFN-α concentrations and an increase in serum RNA expression of IFN-induced genes were observed after treatment. Conclusion: Inhaled IFN-α2b was safe, well-tolerated, and induced systemic biological activity in healthy subjects.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.003 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.003 |
| Insufficient payload (model declined to judge) | 0.007 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".