Clinical trial NCT05651815: Graphene Photothermal Adjuvant Therapy for Mild Corona Virus Disease 2019: A Prospective Randomized Controlled Trial
Official title: Graphene Photothermal Adjuvant Therapy for Mild Corona Virus Disease 2019: A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19
Keywords: Corona Virus Disease 2019
Randomized Control Trial
Adjuvant Therapy
Graphene Photothermal
Lead sponsor: Southeast University, China
Sponsor class: OTHER
Collaborators: name: Hohhot First Hospital
First posted: 2022-12-15
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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℃.

Primary outcomes:
measure: The time from positive at baseline to negative SARS-CoV-2 nucleic acid test
timeFrame: through study completion, an average of 10 days
Secondary outcomes:
measure: Hospital stay
timeFrame: through study completion, an average of 15 days
measure: Negative test rate within 7 days
timeFrame: 7 days
measure: Mild to moderate rate within 14 days
timeFrame: 14 days
Other outcomes:
measure: Lymphocytes variation
timeFrame: through study completion, an average of 15 days
Locations:
city: Hohhot
country: China
facility: Hohhot First Hospital
state: Inner Mongolia
Study officials:
affiliation: Southeast University
name: Songqiao Liu, PhD.
role: STUDY_CHAIR
References: