Graphene Photothermal Adjuvant Therapy for Mild Corona Virus Disease 2019: A Prospective Randomized Controlled Trial

COVID-19 Clinical Trial

Official title:

Graphene Photothermal Adjuvant Therapy for Mild Corona Virus Disease 2019: A Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05651815
• Other study ID #: IRB2022075
• Status: Recruiting
• Phase: N/A
• Start date: November 22, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: December 2022
• Source: Southeast University, China
• Contact: Songqiao Liu, PhD.
• Phone: 086-02583262550
• Email: liusongqiao[@]ymail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a future-proof and randomized controlled clinical study on the clinical efficacy of graphene photothermal adjuvant therapy in Corona Virus Disease 2019(COVID-19) patients with mild symptoms. The objective is to examine the effect of graphene photothermal adjuvant therapy on the time line for such Corona Virus Disease 2019 patients to achieve a negative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleic acid test result, and their duration of disease. Patients who meet study criteria will be randomized into the Grapheme adjuvant therapy combined with conventional therapy group (treatment group) and the conventional therapy only group (control group). Contrasted to the control groups, the treatment groups will undergo 30-min of graphene adjuvant therapy every day for 7 d.

Description:

Following enrollment, patients will be randomized into treatment or control groups. All groups will receive the same conventional therapy.

In addition, treatment groups will undergo Graphene adjuvant therapy 30 minutes per day for 7 d.

Upon completion of the treatment protocol, specific study endpoints will be compared between the treatment and control groups.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 270
• Est. completion date: June 30, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Meet the diagnostic criteria for mild COVID-19.

• Patients aged 18-60 years (inclusive).

• No later than 48 h after testing positive and the onset of clinical symptoms

• Sign informed consent form.

Exclusion Criteria:

• Severe or critically patients with COVID-19.

• Resting heart rate over 120 beats per minute.

• Coronary heart disease patients with acute cardiac insufficiency.

• Acute exacerbation of chronic obstructive pulmonary disease(COPD).

• Uncontrolled hypertension [resting systolic blood pressure(SBP) more than 180 mmHg and diastolic blood pressure(DBP) more than 90 mmHg]; uncontrolled diabetes(Random Plasma Glucose, RPG>16.7mmol/L, HbA1C>7.0%)

• Patients with severe cardiovascular, hepatic, renal and hematopoietic diseases.

• Pregnant or menstruating woman.

• Known or suspected history of active tuberculosis or extrapulmonary tuberculosis, patients with brucellosis, pneumonia-related illness from other causes

• COVID-19 patients for the second or more times

• Those who cannot cooperate due to various reasons

• Body temperature: more than 38?.

Related Conditions & MeSH terms

• Coronavirus Infections
• COVID-19
• Virus Diseases

Intervention

Device:
• Graphene spectrum light wave therapy room
Undergo 30-min of graphene adjuvant therapy every day for 7 d.

Locations

Country	Name	City	State
China	Hohhot First Hospital	Hohhot	Inner Mongolia

Sponsors (2)

Lead Sponsor	Collaborator
Southeast University, China	Hohhot First Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Lymphocytes variation	Lymphocytes count	through study completion, an average of 15 days
Primary	The time from positive at baseline to negative SARS-CoV-2 nucleic acid test	The time for grouped patients to receive a negative SARS-CoV-2 nucleic acid test result, including both ORF gene Ct value=35 and N gene Ct value=35.	through study completion, an average of 10 days
Secondary	Hospital stay	Time to hospitalization for COVID-19	through study completion, an average of 15 days
Secondary	Negative test rate within 7 days	the rate of negative test of patients	7 days
Secondary	Mild to moderate rate within 14 days	Mild to moderate rate within 14 days	14 days