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The present study aims to define the possible responses of the clinical entity now known as "long-term" COVID-19, to an intervention using light of specific wavelengths.

This work was preceded by another, a survey whose results can be found at LTCOVID.com.

The principal findings there, also documented by many other investigators, include the following:

1. 1. the "long-term" variant of the COVID-19 illness gets its name from unusually prolonged duration of a viral illness, an average duration of 6.6 months in our prior study.
   2. The number of symptoms experienced by those affected, is surprisingly large.
   3. These symptoms are both physical and emotional. Our estimate based on these survey findings is that 70% of symptoms are physical and 30% can be categorized as emotional.

These preliminary results have led to three hypothetical suggestions:

1. 1. That the symptom complex presenting in "long-term" COVID-19 derives from a problem originating in a disturbance of cellular energetics.
   2. That this viral illness, in search during its acute phase of an energy source for its replication, has essentially hijacked cellular organelles and specifically, mitochondria, and in doing so has damaged these.
   3. That this damage may be amenable to an intervention using specific wavelengths of light is the key hypothesis that will be tested in this protocol.

The prior study relied primarily on subjective impressions of this illness. Some objective data such as the age, race, body size, and presence or absence of smoking, use of nutritional supplements and country a respondent was located allowed further grouping of the results, thereby permitting several comparisons.

While also including subjective assessments in the present protocol, other objective variables have also been added to the study. These include: measurement of basic vital signs, and the effect of a very short and very mild exercise routine on these values.

While less described in the literature at the present time, an assessment of visual acuity will be made at appropriate intervals in the present study. While this is thought of as primarily being a respiratory illness, with the virus gaining access through the nasopharynx and orally, entry into the body through the eyes has also been documented. It is interesting that some subjects suffering infection with the SARS-CoV-2 virus, and who had a negative nasopharyngeal swab, nevertheless had a positive swab of the corneal surfaces.

Since this illness has been associated with signs and effects attributable to an inflammatory response of the host, such changes will also be pursued with measurements of serum values known to be elevated in certain inflammatory states.

Several questionnaires have been formulated to study those enrolled in the present work.
These aim to capture subjective impressions of symptom severity at different times. The questions themselves have been selected based on symptom frequencies discovered in the prior work.

Going one step beyond assessment of physical and emotional symptoms, a series of questions related to mental status and executive mental functions will also be pursued by a short questionnaire.

The present study has been formulated as a randomized, double-blind, crossover intervention. Criteria for enrollment will be described subsequently.

The above mentioned methods for extensive data gathering will be repeated four times.

1. 1. At baseline, before any intervention (Day 1).
   2. At the crossover point (Day 11)
   3. At the end of the interventions (Day 21)
   4. At ten days after the last day of intervention (Day 31).

The intervention consists of the following:

1. 1. A light source incorporates nine LEDs that emit red light at a wavelength of 660 nm.
      The same device incorporates nine LEDs that emit near infrared light at a wavelength of 830 nm.
   2. During the intervention, enrollees direct this device towards the skin for a period of 10 minutes. Measurements made of the irradiance of this device allow one to say that an energy density of 40 J/ cm² at skin surface will obtain during this 10 minutes. Irradiance of course varies with the distance from device to skin surface. For this device, a distance of 1.25 cm from the skin generates the required energy density. As a reminder, these lamps have been equipped with a 1.25 cm thick smooth wooden piece glued in the center of the illuminating surface. We note here that these lamps generate no significant amounts of heat. Skin burns are not reported from these wavelengths or the devices emitting them, even in direct contact with the skin.
   3. A second lamp, quite similar in appearance is used as a sham treatment. This device emits red light at a frequency of 622-630 nm.
   4. In this protocol, each enrollee will receive interventions using both devices. The device in use will be changed at the crossover point in the study (after Day 10, before Day 11). This process will be blinded in that neither the enrollee nor the principal investigator will know which device was used first and which second, until after the study has been completed. The appearance of these devices are essentially identical and permit this division into actual and sham interventions. This level of deceit is necessary to permit meaningful comparisons. It will be underscored in the instructions for each enrollee that ultimately each enrollee will receive the intervention felt hypothetically to be of potential use in the setting of "long-term" COVID-19. This, if not in the first 10 days of the study, in the second 10 days.
      
      It is mentioned here that these wavelengths of light, and the energy densities associated with their use as included in this protocol have been proven safe. This can be affirmed by reviewing their use in many human research protocols that precede this one, and as already referred to on previous pages. In addition, devices that emit similar wavelengths have been approved by the FDA and other regulatory agencies for sale to the general public. More pertinent to this study, the application of these wavelengths in studying mitochondrial function and their use in the setting of COVID-19, have been presented on the LTCovid.com site.
      
      

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