Study design and participants
ICH, allergy
COMMON COLDS, ALLERGY, COMMON COLD, COLD SYMPTOMS, DER, INFLUENZA
This trial was conducted between January and April 2019, prior to the global outbreak of SARS-CoV-2 [registered at ClinicalTrials.gov, NCT03794804]. It was a prospective, multicenter, randomized, double-blind study to evaluate the efficacy of ColdZyme for common cold using a parallel-group design that compared the investigational device to placebo in subjects with naturally occurring common colds. After approval from four local Ethics Committees (Ethikkommission der Charité, Berlin; Landesärztekammer Brandenburg, Cottbus; Sächsische Landesärztekammer, Dresden; and Landesärztekammer Baden-Württemberg, Stuttgart) and after providing written informed consent, subjects were recruited to ten health care centers in Germany.Men and women (18–70 years) with at least three occurrences of common cold within the previous 12 months, but otherwise in good health and willing to comply with the trial procedures, were eligible and screened for enrolment at the study sites against inclusion and exclusion criteria. Women of child-bearing potential had to use appropriate contraception methods and demonstrate a negative pregnancy test at enrolment. Exclusion criteria included known allergy to the components of the investigational product, a health condition which could interfere with the results of the study or the safety of the subject, influenza vaccination within three months prior to enrolment, and regular use of products that may influence the study outcome, except for the defined optional care. Pregnancy or nursing, history of or current abuse of drugs, alcohol or medication, participation in the present study of a person living in the same household as the subject, inability to comply with study requirements according to investigator’s judgement or participation in another clinical study in the 30 days prior to enrolment and during the study, were also exclusion criteria. The inclusion and exclusion criteria were identical to the criteria in the previous trial [After enrolment and randomization, the study was conducted in an initial surveillance phase (checking daily for any onset of the common cold symptoms, documented in the diary), followed by a treatment phase initiated once the participants experienced first perception of a common cold. During the conduct of the study the number of subjects to be enrolled was raised from 600 to 701 in order to reach the required number of subjects experiencing common cold symptoms.Prior to enrolment the trial was registered at ClincialTrials.gov, number NCT03794804. The trial was performed in compliance with the principles of the World Medical Association (Declaration of Helsinki), ICH GCP E6, German Act on Medical Devices (MPG) §23b and ISO 14155.