Common ColdPhase 3NCT05273619

Efficacy and Safety of XC8, Film-coated Tablets, 40 mg in Patients With Dry Non-productive Cough Against Acute Respiratory Viral Infection

A Phase 3 study testing XC8, film-coated tablets, 10 mg in people with Common Cold and Acute Respiratory Infection, run by Valenta Pharm JSC at 6 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Study to assess the efficacy and safety of XC8, film-coated tablets, 10 mg in comparison with placebo in patients with dry non-productive cough against acute respiratory infection. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Common Cold, Acute Respiratory Infection, Influenza, Human
What is being tested?: XC8, film-coated tablets, 10 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 250 participants
Where: 6 sitesRussia
Study dates: 23 May 2022to 29 Jul 2022
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Signing and dating of the IPP informed consent form by the patient.
Women and men between the ages of 18 and 65 years, inclusive, at the time of signing the informed consent form.
Clinical diagnosis of acute respiratory viral infection of the upper respiratory tract (ICD-10 code J00-J06) or acute bronchitis (J20, J21 according to ICD-10).
Onset of disease symptoms no more than 3 days prior to screening.
Presence of a patient with a dry unproductive cough.
Frequency of cough episodes ≥10 in the past 24 h before the screening visit and randomization.

Show all 10Show fewer

Cough frequency rated by the patient as 3-4 on the daytime cough section and 2-4 on the nighttime cough section of the Daytime and Nighttime Cough Scales.
Patient rating of cough severity on the DRS ≥ 4 points.
No indication for therapy due to BHSA infection at the time of study inclusion: negative rapid test for Group A β-haemolytic streptococcus.
For women of preserved reproductive potential, a negative pregnancy test and agreement to use approved contraceptive methods for the duration of study participation, beginning at visit 0, and for 3 weeks after the end of the study; for men, agreement to use approved contraceptive methods throughout the study participation period and for 3 weeks after the end of the study.

Who cannot join

Known or suspected hypersensitivity to the active ingredient or any of the excipients of the study drug/placebo.
Known or suspected hypersensitivity to acetylcysteine.
Lactose intolerance, lactase deficiency, glucose-galactose malabsorption.
Trauma (including open wounds in the mouth and erosive-desquamous lesions of the oral mucosa) and/or oropharyngeal burns, scarlet fever, rubella, measles, mumps at the time of screening or within 3 months prior to screening.
Acute obstructive laryngitis or suspected obstructive laryngitis.
Presence of signs of laryngeal stenosis (stridor, shortness of breath).

Show all 46Show fewer

Exacerbation of chronic bronchitis or chronic obstructive pulmonary disease (COPD).
Bronchial asthma, including a history.
History of tuberculosis.
History of pulmonary emphysema.
Acute or chronic pneumonia, or suspected pneumonia.
Condition after intubation.
Gastroesophageal reflux being the primary cause of cough (as judged by the investigating physician).
Allergic rhinitis as primary cause of cough (according to study physician).
Body temperature > 39.0 °C.
Presence of at least one of the epidemic signs: return from a foreign trip 14 days prior to the onset of symptoms; presence of close contact in the past 14 days with a person under COVID-19 surveillance who has subsequently become ill; having close contact in the past 14 days with a person who has a laboratory-confirmed diagnosis of COVID-19; having occupational contacts with an individual with a suspected or confirmed case of COVID-19.
Positive result of laboratory testing for SARS-CoV-2 RNA using nucleic acid amplification techniques or SARS-CoV-2 antigen using immunochromatographic analysis at the time of screening.
The need for systemic antibiotic therapy and/or other drugs/procedures from the list of prohibited therapies/procedures.
Use of analgesics or antipyretics within 12 hours prior to screening.
Use of glucocorticosteroids, β-adrenoblockers, ACE inhibitors, theophylline drugs, expectorants, cough suppressants, anesthetics, anti-allergic drugs (leukotriene receptor antagonists, H1-histamine receptor blockers, sodium cromoglycate preparations), antiviral drugs, immunosuppressants, systemic antibacterial drugs for 7 days before screening.
History of smoking more than 10 pack/years (pack-years: number of cigarettes smoked per day multiplied by the number of years of smoking divided by 20).
Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) levels ≥ 2.5 × highest normal value, serum bilirubin levels ≥ 1.5 × highest normal value.
Glomerular filtration rate (GFR) ≤ 60 ml/min.
History of cancer of the respiratory system.
History of other malignancies, except for patients who have not had the disease in the past 5 years, patients with fully cured basal cell carcinoma of the skin, or fully cured carcinoma in situ.
Serious cardiovascular disease at the time of screening or within 12 months prior to screening, including: New York Heart Association Class III or IV chronic heart failure, severe arrhythmias requiring treatment with antiarrhythmic drugs, unstable angina pectoris, myocardial infarction, heart and coronary artery surgery, transient ischemic attack or stroke, uncontrolled hypertension with systolic blood pressure > 180 mm Hg Std. and diastolic blood pressure >110 mmHg, pulmonary embolism.
Other severe, decompensated or unstable somatic diseases (any disease or condition that threatens the patient's life or worsens the patient's prognosis, or makes it impossible for the patient to participate in a clinical trial).
Patient's unwillingness or inability to comply with protocol procedures (in the opinion of the research physician).
Pregnancy or breastfeeding (for women).
Alcoholism, drug dependence, substance abuse history and/or at the time of screening.
A history of schizophrenia, schizoaffective disorder, bipolar disorder or other psychiatric pathology.
Participation in another clinical trial within 3 months prior to inclusion in the study.
Other conditions that, in the opinion of the investigating physician, preclude inclusion of the patient in the study.
Withdrawal Criteria:
Identification of a probable or confirmed case of COVID-19
Ineffectiveness of therapy - persistence or increased frequency of cough attacks ≥ 1 by visit 3 (day 8-9) compared to visit 1 (day 1).
AEs requiring withdrawal of study drug/placebo.
The occurrence of any disease or condition during the study that, in the opinion of the study physician, worsens the patient's prognosis and also makes it impossible for the patient to continue participating in the clinical trial.
Erroneous inclusion of a patient who does not meet the inclusion criteria and/or meets the inclusion criteria.
Taking any of the drugs of prohibited therapy, performing a prohibited procedure.
The necessity of prescribing prohibited concomitant therapy/procedures.
Pregnancy of the patient.
Patient's desire to stop participating in the study.
Lack of adequate cooperation of the patient with the doctor-researcher during the study.
Other protocol violations that are significant in the opinion of the physician-researcher.
Other administrative reasons.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

Russia6 sites

Ivanovo Kuvaev Clinical Hospital
Ivanovo, 153025
Federal State Budgetary Educational Institution of Higher Education "Kirov State Medical University" of the Ministry of Healthcare of the Russian Federation
Kirov, 610027
Unimed-C Jsc
Moscow, 119571
EosMED JSC
Saint Petersburg, 194000
OrKli Hospital LLC.
Saint Petersburg, 199178
Uromed LLC
Smolensk, 214031

Other trials in Russia

About this study

Official title: Double-blind Placebo-controlled Multicenter Randomized Clinical Trial to Assess Efficacy and Safety of XC8, Film-coated Tablets, 40 mg in Patients With Dry Non-productive Cough Against Acute Respiratory Viral Infection

Study to assess the efficacy and safety of XC8, film-coated tablets, 10 mg in comparison with placebo in patients with dry non-productive cough against acute respiratory infection.

Conditions: Common Cold, Acute Respiratory Infection, Influenza, Human
Being tested: XC8, film-coated tablets, 10 mg, Placebo
Medical subject headings: Common Cold, Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

XC8, film-coated tablets, 10 mgDrug
80 mg/day: 4 tablets (40 mg) twice a day
PlaceboDrug
4 tablets twice a day

Study groups in NCT05273619
Study group	Role	What they receive
XC8, film-coated tablets, 10 mg	Experimental	Not described Receives: Drug: XC8, film-coated tablets, 10 mg
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Coughing frequency
Reduced coughing frequency by ≥50% by day 5 relative to visit 1
Measured: The estimate will include data from 24 hours to Day 1 and Day 5

Secondary outcomes (13)

Frequency of cough episodes
Frequency of cough episodes by 5, 8, 11, and 15 days after visit 1
Measured: The assessment will include data for 24 h before days 5, 8, 11, and 15, respectively.
Time to clinical cough cure
Time (days) from visit 1 to achievement of clinical cough cure. Clinical cough cure is defined as having ≤ 1 score on the Daytime Cough and Nighttime Cough Scales for at least 3 consecutive days.
Measured: The assessment will include the time from visit 1 to the first day of consecutive days on which ≤ 1 point on the Daytime Cough and Nighttime Cough Scales sections of the Daytime and Nighttime Cough Scales is recorded.
Proportion of patients with ≤ 1 score on the daytime cough and nighttime cough Scales sections
Proportion of patients with ≤ 1 score on the daytime cough and nighttime cough Scales sections by days 5, 8, 11, and 15 after visit 1
Measured: The daytime cough section score will include data for days 4, 7, 10, and 14, respectively. The nighttime cough section score will include data for the night preceding days 5, 8, 11, and 15, respectively.
Change (score) in cough severity
Change (score) in cough severity according to the digital rating scale (DRS) by days 5, 8, 11, and 15 compared to visit 1.
Measured: The score will include data 24 h before days 5, 8, 11, and 15, respectively.
Percentage of patients prescribed acetylcysteine
Percentage of patients who were prescribed acetylcysteine for the conversion of dry to wet cough.
Measured: From Day 1 (visit 1) up to Day 16 (visit 5)
Percentage of patients with complete resolution of all symptoms
Percentage of patients with complete resolution of all acute respiratory infection symptoms by days 4, 7, 10, and 14.
Measured: Assessment will include data for days 4, 7, 10, and 14, respectively.
Proportion of patients with "very high" and "high" efficacy
Proportion of patients with "very high" and "high" efficacy at visits 2, 3, 4, and 5 by physician's assessment.
Measured: From Day 3-4 (visit 2) up to Day 16 (visit 5)
Proportion of patients with each category of Global Assessment scale
Proportion of patients with each category of Global Assessment by the physician at visits 2, 3, 4, and 5.
Measured: From Day 3-4 (visit 2) up to Day 16 (visit 5)
Safety - Adverse Events (AEs)
Total number of AEs stratified by severity and frequency
Measured: From visit 0 up to Day 20 +/- 2 (visit 6).
Safety - Adverse Reactions
Frequency of Adverse Reactions
Measured: From visit 0 up to Day 20 +/- 2 (visit 6).
Safety - Serious adverse events (SAEs)
Frequency of SAEs associated with the use of the study drug/placebo
Measured: From visit 0 up to Day 20 +/- 2 (visit 6).
Safety - Percentage of patients with at least one AE
Percentage of patients with at least one AE
Measured: From visit 0 up to Day 20 +/- 2 (visit 6).
Safety - Percentage of patients who interrupted the treatment due to AE
Percentage of patients who interrupted the treatment due to the occurrence of AE
Measured: From visit 0 up to Day 20 +/- 2 (visit 6).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 May 202229 Jul 2022

First posted10 Mar 2022
Study start23 May 2022
Primary completion13 Jul 2022
Study completion29 Jul 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Common ColdStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 250 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05273619
Sponsor's protocol ID: XC8-03-03-2021
Status last verified: Jul 2023
First submitted: 28 Jan 2022
Last updated: 27 Jul 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Double-blind Placebo-controlled Multicenter Randomized Clinical Trial to Assess Efficacy and Safety of XC8, Film-coated Tablets, 40 mg in Patients With Dry Non-productive Cough Against Acute Respiratory Viral Infection
ClinicalTrials.gov ID: NCT05273619
Acronym / sponsor ID: XC8-03-03-2021
Conditions: Common Cold, Acute Respiratory Infection, Influenza, Human
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 250 participants (actual)
Lead sponsor: Valenta Pharm JSCIndustry (pharma, biotech, devices)
Study start: 23 May 2022 (actual)
Primary completion: 13 Jul 2022 (actual)
Study completion: 29 Jul 2022 (actual)
First posted: 10 Mar 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study to assess the efficacy and safety of XC8, film-coated tablets, 10 mg in comparison with placebo in patients with dry non-productive cough against acute respiratory infection.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
XC8, film-coated tablets, 10 mg	Experimental	Drug: XC8, film-coated tablets, 10 mg
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Signing and dating of the IPP informed consent form by the patient.
Women and men between the ages of 18 and 65 years, inclusive, at the time of signing the informed consent form.
Clinical diagnosis of acute respiratory viral infection of the upper respiratory tract (ICD-10 code J00-J06) or acute bronchitis (J20, J21 according to ICD-10).
Onset of disease symptoms no more than 3 days prior to screening.
Presence of a patient with a dry unproductive cough.

Key exclusion criteria (46 listed)

Known or suspected hypersensitivity to the active ingredient or any of the excipients of the study drug/placebo.
Known or suspected hypersensitivity to acetylcysteine.
Lactose intolerance, lactase deficiency, glucose-galactose malabsorption.
Trauma (including open wounds in the mouth and erosive-desquamous lesions of the oral mucosa) and/or oropharyngeal burns, scarlet fever, rubella, measles, mumps at the time of screening or within 3 months prior to screening.
Acute obstructive laryngitis or suspected obstructive laryngitis.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
XC8, film-coated tablets, 10 mg80 mg/day: 4 tablets (40 mg) twice a day	Drug	XC8, film-coated tablets, 10 mg
Placebo4 tablets twice a day	Drug	Placebo

Primary outcome

Coughing frequency
Time frame: The estimate will include data from 24 hours to Day 1 and Day 5
Reduced coughing frequency by ≥50% by day 5 relative to visit 1

13 secondary outcomes

Frequency of cough episodes
Time frame: The assessment will include data for 24 h before days 5, 8, 11, and 15, respectively.
Time to clinical cough cure
Time frame: The assessment will include the time from visit 1 to the first day of consecutive days on which ≤ 1 point on the Daytime Cough and Nighttime Cough Scales sections of the Daytime and Nighttime Cough Scales is recorded.
Proportion of patients with ≤ 1 score on the daytime cough and nighttime cough Scales sections
Time frame: The daytime cough section score will include data for days 4, 7, 10, and 14, respectively. The nighttime cough section score will include data for the night preceding days 5, 8, 11, and 15, respectively.
Change (score) in cough severity
Time frame: The score will include data 24 h before days 5, 8, 11, and 15, respectively.
Percentage of patients prescribed acetylcysteine
Time frame: From Day 1 (visit 1) up to Day 16 (visit 5)
Percentage of patients with complete resolution of all symptoms
Time frame: Assessment will include data for days 4, 7, 10, and 14, respectively.
Proportion of patients with "very high" and "high" efficacy
Time frame: From Day 3-4 (visit 2) up to Day 16 (visit 5)
Proportion of patients with each category of Global Assessment scale
Time frame: From Day 3-4 (visit 2) up to Day 16 (visit 5)
Safety - Adverse Events (AEs)
Time frame: From visit 0 up to Day 20 +/- 2 (visit 6).
Safety - Adverse Reactions
Time frame: From visit 0 up to Day 20 +/- 2 (visit 6).
Safety - Serious adverse events (SAEs)
Time frame: From visit 0 up to Day 20 +/- 2 (visit 6).
Safety - Percentage of patients with at least one AE
Time frame: From visit 0 up to Day 20 +/- 2 (visit 6).
Safety - Percentage of patients who interrupted the treatment due to AE
Time frame: From visit 0 up to Day 20 +/- 2 (visit 6).

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.

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Not yet recruitingObservational study
Post-market Clinical Follow-up Study of an Isotonic Saline Solution for the Relief of Nasal Congestion in Infants and Toddlers
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing XC8, film-coated tablets, 10 mg in people with Common Cold and Acute Respiratory Infection, run by Valenta Pharm JSC at 6 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 46 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Coughing frequency (time frame: The estimate will include data from 24 hours to Day 1 and Day 5). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05273619.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.