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Completed

NCT Number: NCT04391712

Photobiomodulation Laser Therapy for COVID-19 Positive Patients With Pulmonary Disease

The aim of this study is to evaluate the effectiveness of MLS laser therapy as a treatment for pulmonary complications due to COVID-19 infection.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Lowell General Hospital

Lowell, Massachusetts, 01854, United States

About this study

Participants will be randomized into treatment vs. control group. Both groups will receive regular inpatient medical treatment. Participants in the experimental arm will receive laser treatments once daily for 4 days. Treatments will be delivered to the patients in a prone position using a 10 by 25 cm laser field across each lung with 7j/cm2 at 1500 Hz. Standard nursing protocols would be used to identify participant's pulmonary status throughout treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • COVID-19 positive
  • Pulmonary compromise requiring oxygen support of approximately 2-6 liters
  • Able to self prone, or support in self-sitting position

Exclusion criteria

  • Ventilator management
  • Patients with autoimmune disorders or inflammatory conditions not related to COVID-19
  • Pregnant women

Treatment and study plan

MLS laser

Device

Treatments will be delivered to the participants days 1-4, in a prone position using a 10 by 25 cm laser field across each lung with 7j/cm2 at 1500 Hz.

Regular Inpatient Medical Care

Other

Regular inpatient medical care

Primary outcomes

  1. Patient Disposition Post treatment

    Time frame: 7 days

    ICU on vent, ICU not requiring ventilation, Discharge to Rehab requiring assistance, Discharge to Home unable to perform ADL's, Discharge to Home able to perform ADL's

  2. oxygenation

    Time frame: Daily for 4 days

    Patients oxygen requirements pulse oximetry will be evaluated for change from pre and post individual treatment as well as end of protocol

  3. IL-6 levels

    Time frame: First four days of trial

    The change in pre treatment levels and 24 hours post final treatment

  4. Chest Xray radiographic results

    Time frame: 7 Days

    Pre treatment CXR will be compared to post treatment CXR using the RALE CXR evaluation scale

  5. Brescia-COVID Respiratory Severity Scale

    Time frame: 7 days

    The change in pretreatment and post treatment BCRSS will be evaluated

  6. SMART-COP Score

    Time frame: 7 days

    The change in pretreatment and post treatment scores will be evaluated

  7. PSI Score

    Time frame: 7 days

    The change in pretreatment and post treatment scores will be evaluated

  8. CRP levels

    Time frame: 7 days

    The change in pretreatment and post treatment levels will be evaluated The change in pretreatment and post treatment levels will be evalutated

Sponsors and collaborators

Lead sponsor

Lowell General Hospital

Other

Registry information

Official study title

Multiwave Locked System (MLS) Laser Therapy for COVID-19 Positive Patients With Pulmonary Disease

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 18, 2020
Registry last updated
Aug 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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